An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel

April 21, 2025 updated by: HALEON

A Randomized, Examiner Blind, Crossover, in Situ Erosion Study To Investigate The Efficacy Of An Experimental Dentifrice In Remineralization Of Softened Enamel Compared To Placebo and Reference Dentifrices

The purpose of this study is to investigate the ability of an experimental dentifrice containing 1150 parts per million (ppm) fluoride to remineralize acid-softened dental enamel and help prevent further demineralization compared to a 0 ppm fluoride placebo dentifrice and a marketed, fluoride-containing dentifrice (Reference Dentifrice).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a randomized, controlled, single center, single-blind, 3 period, 3 treatment, cross-over, in situ design study. Previously demineralized bovine enamel specimens will be placed intra orally using a palatal appliance and the remineralizing performance of the experimental, reference and placebo dentifrices will be evaluated at 4 and 12 hours post toothbrushing, based on surface micro hardness measurements of the bovine enamel specimens. At each treatment visit, once the palatal the appliance is fitted in the mouth, a five minute equilibration period will ensue following which each participant will brush their teeth with their assigned product. Participants will remove the appliance for 30 minutes at 4 and 8.5 hours post brushing and will remove and store the appliance 13 hours post brushing (12 hours intraoral exposure). Sufficient participants will be screened to randomize approximately 33 participants to study treatment to ensure approximately 30 participants complete the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Oral Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Participant is of either sex and any gender who, at the time of screening, is between the ages of 18-65 years, inclusive.
  • Participant is willing and able to comply with scheduled visits, and other study procedures and restrictions.
  • Participant is in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.

  • Participant with generally good oral health that fulfil all of the following:

    1. Having an unstimulated salivary flow rate of at least 0.2 milliliter per minute (mL/minute) and a stimulated salivary flow rate of at least 0.8 mL/minute.
    2. Having a maxillary dental arch suitable for the retention of the palatal appliance.
    3. Having no lesions of the oral cavity that could interfere with the study evaluations.

Exclusion Criteria:

  • Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family (employees of the study site and associated academic institutes who are not directly involved in the conduct of the study are eligible to be considered as participants.)
  • Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
  • Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • Participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
  • Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • A participant who, in the opinion of the investigator or medically qualified designee, can't comply with study requirements or who should not participate in the study for other reasons.
  • Participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
  • Participant taking medication that may interfere significantly with the saliva flow in the judgment of the investigator. Should new medications that may interfere with the saliva flow be added, a second salivary flow test will be performed.
  • Participant with any condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements.
  • Participant with any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear. Participant presenting at screening with minor caries may continue in the study if their carious lesions are repaired prior to the first treatment visit of the study.
  • Participant who wears an oral piercing or oral appliance or orthodontia (besides participants wearing permanent lower retainers, which are eligible).
  • Participant who has previously been enrolled in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Dentifrice
Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 grams (g) of the experimental dentifrice containing 1150 ppm fluoride and 5 percent (%) potassium nitrate (KNO3) for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.
Drug: Experimental Dentifrice
Dentifrice containing 1150 ppm fluoride and 5% KNO3.
Placebo Comparator: Placebo Control Dentifrice
Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the placebo dentifrice containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.
Drug: Placebo Control Dentifrice
Dentifrice containing 0 ppm fluoride and 5% KNO3.
Active Comparator: Reference Dentifrice
Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the reference dentifrice containing 1100 ppm fluoride as stannous fluoride (SnF2) for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.
Drug: Reference Dentifrice
Dentifrice containing 1100 ppm fluoride as SnF2.
Other Names:
  • Crest Pro-Health Densify Daily Protection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adjusted Mean Percent Surface Microhardness Recovery (%SMHR) at 4 Hours (Test Dentifrice Versus (vs.) Placebo Control Dentifrice)
Time Frame: At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface microhardness (SMH) technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (micrometre [μm]) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization.
At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adjusted Mean Percent Relative Erosion Resistance (%RER) at 4 Hours (Test Dentifrice vs. Placebo Control Dentifrice)
Time Frame: At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
%RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice).
At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean %SMHR at 4 Hours (Test Dentifrice vs. Reference Dentifrice)
Time Frame: At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization.
At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean %SMHR at 12 Hours
Time Frame: At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 12 hours in situ remineralization.
At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean %RER at 4 Hours (Test Dentifrice vs. Reference Dentifrice)
Time Frame: At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
%RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice).
At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean %RER at 12 Hours
Time Frame: At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
%RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice).
At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean Enamel Fluoride Uptake (EFU) at 4 and 12 Hours
Time Frame: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
EFU is a measure of how much fluoride has been incorporated into the enamel during the process of remineralization. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and chemically analyzed to measure the amount of fluoride incorporated into the enamel by the dentifrice treatment.
At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean Acid Resistance Ratio (ARR) at 4 and 12 Hours
Time Frame: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
ARR was used to measure the resistance of the remineralized enamel to further acid softening. SMH technique was used to calculate ARR. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate ARR. The ARR was derived as 1 - [(E2-R)/(E1-B)] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization.
At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean %SMHR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
Time Frame: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatment in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization.
At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean %RER at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
Time Frame: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
%RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice).
At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean EFU at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
Time Frame: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
EFU is a measure of how much fluoride has been incorporated into the enamel during the process of remineralization. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and chemically analyzed to measure the amount of fluoride incorporated into the enamel by the dentifrice treatment.
At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
Adjusted Mean ARR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
Time Frame: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
ARR was used to measure the resistance of the remineralized enamel to further acid softening. SMH technique was used to calculate ARR. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to yield ARR. The ARR was derived as 1 - [(E2-R)/(E1-B)] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization.
At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HALEON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 300057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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