Evaluation of Dentifrice Formulations to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind In-Situ Clinical Trial

November 14, 2023 updated by: Procter and Gamble

Evaluation of Efficacy of Experimental Dentifrice Formulations With Different Forms of Fluoride and/or Other Agents to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind Randomized In-Situ Clinical Trial

To compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with five different aqueous slurries of toothpaste formulations. Percent remineralization (%R), i.e. the % change in ΔZ values relative to ΔZd, will be the primary outcome measure.

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.

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.
10

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 Locations

  • Australia
      • Melbourne, Australia
        • University of Melbourne

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:

  • Be 18-75 years of age;
  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Be in good general health based on medical/dental history and oral exam;
  • Have no history of adverse or allergic reactions to tin or tin-containing products;
  • Agree not to participate in any other oral study for the study duration;
  • Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance;
  • Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time;
  • Be willing to refrain from using non-study dentifrice, mouth rinse, chewing gum, and other non-study oral care products during the study;
  • Be willing to postpone all elective dental procedures until the study has been completed;
  • Be willing to refrain from using calcium chews while using the test products;
  • Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).
  • Ability to understand, and ability to read and sign, the informed consent form;
  • Have at least 22 natural teeth;
  • Have a gum-stimulated whole salivary flow rate ≥1.0 ml/minute and unstimulated whole salivary flow rate ≥ 0.2 ml/minute.
  • Willingness to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

  • Advanced periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
  • Active treatment for periodontitis;
  • A medical condition which requires premedication prior to dental visits/procedures;
  • Untreated dental problems (e.g. cavities);
  • Self-reported pregnancy or plans to become pregnant during the study;
  • Existing dental work which prevents wearing of the appliance including orthodontic appliances or removable dentures;
  • Chronic disease such as diabetes or use of medications that cause gum swelling;
  • Any diseases or conditions (including sensitivity to dentifrice ingredients or a history of allergic or adverse reactions to tin or tin-containing products) that might interfere with examination procedures or the participant safely completing the study;
  • Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study;
  • Use of drugs that may interact with the toothpaste slurries or which may affect salivary flow rate;
  • History of health conditions requiring antibiotic coverage prior to dental treatment;
  • Serious infectious disease;
  • Any other medical or dental conditions deemed to put the health and wellbeing of the participant or research team at risk if the potential participant participated in the 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: Triple

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.
Placebo Comparator: 0 ppm Fluoride Dentifrice 1
Drug: 0 ppm Fluoride Dentifrice 1
Each subject will use this product during one of the five treatment periods in the crossover study design.
Active Comparator: 1100 ppm NaF Fluoride Dentifrice
Drug: 1100 ppm NaF Fluoride Dentifrice
Each subject will use this product during one of the five treatment periods in the crossover study design.
Active Comparator: 1500 ppm NaMFP Fluoride Dentifrice
Drug: 1500 ppm NaMFP Fluoride Dentifrice
Each subject will use this product during one of the five treatment periods in the crossover study design.
Sham Comparator: 0 ppm Fluoride Dentifrice 2
Drug: 0 ppm Fluoride Dentifrice 2
Each subject will use this product during one of the five treatment periods in the crossover study design.
Sham Comparator: 0 ppm Fluoride Dentifrice 3
Drug: 0 ppm Fluoride Dentifrice 3
Each subject will use this product during one of the five treatment periods in the crossover study design.

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
Mineral Density
Time Frame: 14 days
The percent mineral profile of each enamel/dentinel slab's demineralized control and remineralized/treated lesion, obtained from the microdensitometry analysis, will be compared with the median sound enamel percent mineral profile of the same section. A negative value indicates mineral has been lost and, therefore, the lesion has progressed, whereas a positive value indicates mineral has been gained and, therefore, the lesion has regressed.
14 days
Scanning Electron Microscopy (SEM)
Time Frame: 14 days
SEM imaging and SEM-EDS analysis will be conducted on TMR sections and whole sections of dentine lesions treated in situ to assess the occlusion of dentine tubules and distribution of elements within the lesions following the experiment.
14 days

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.
Procter and Gamble

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.
October 5, 2020

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.
February 21, 2021

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.
February 21, 2021

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).
November 14, 2023

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.
November 14, 2023

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.
November 20, 2023

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.
November 20, 2023

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.
November 14, 2023

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.
November 1, 2023

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.
  • 2019176

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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