Management of Dentinal Hypersensitivity Using Two Dentifrice Technologies

April 9, 2026 updated by: Prof. Mayyas Al-Remawi

Post Marketing Study to Evaluate the Efficacy of Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash in Tooth Whitening and Treating Tooth Sensitivity in a Control Group Using Standardized Methods and Criteria

This study evaluates the effectiveness of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash in reducing tooth sensitivity and improving tooth whitening compared to Lacalut® White & Repair toothpaste. Participants will be randomly assigned to either the Scigates group or the Lacalut control group and will use the assigned product three times daily for 8 weeks. Tooth sensitivity and dental staining will be assessed at multiple time points using standardized clinical scales. Safety will also be monitored throughout the study.

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 study is a randomized, parallel-group, controlled post-marketing clinical trial designed to evaluate the efficacy and safety of Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash compared to Lacalut® White & Repair toothpaste in reducing tooth sensitivity and improving tooth whitening.

Healthy adult participants aged 18 to 65 years with mild to moderate tooth staining and self-reported tooth sensitivity were enrolled and randomly assigned to either the test group, receiving Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash, or the control group, receiving Lacalut® White & Repair toothpaste. Participants used the assigned product three times daily for a period of 8 weeks according to standardized instructions.

A total of 57 participants were enrolled. The study was conducted as an exploratory post-marketing investigation and was concluded at this sample size to provide preliminary estimates of treatment effects, variability, and feasibility, which may inform the design and statistical powering of future larger-scale confirmatory studies.

Efficacy was assessed using validated clinical measures. Tooth sensitivity was evaluated using the Schiff Cold Air Sensitivity Scale, and dental extrinsic staining was assessed using the Modified Lobene Stain Index. Assessments were conducted at baseline and at weeks 1, 2, 4, and 8 to monitor changes over time.

Safety was evaluated throughout the study by recording adverse events and conducting clinical assessments. Participants were instructed to avoid the use of other dental treatments during the study period unless approved by the investigator.

Data were analyzed using appropriate statistical methods, including parametric and non-parametric tests, with an intention-to-treat approach. The study was conducted in accordance with Good Clinical Practice guidelines and ethical principles outlined in the Declaration of Helsinki.

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.
57

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

  • Jordan
      • Amman, Jordan, 11196
        • University of Petra

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:

  • Healthy male or female participants aged 18 to 65 years
  • Individuals with mild to moderate tooth staining
  • Individuals with self-reported tooth sensitivity to hot, cold, sweet, or acidic stimuli
  • Ability and willingness to comply with all study procedures
  • Provision of written informed consent

Exclusion Criteria:

  • History of allergic reactions to any component of the study products
  • Presence of clinically significant allergic disease
  • Pregnant or lactating women
  • Women of childbearing potential not using an acceptable method of contraception
  • Individuals with severe tooth staining requiring professional treatment
  • Individuals who have received recent treatment for tooth discoloration
  • Individuals with severe periodontal disease requiring immediate intervention
  • Individuals with significant dental conditions such as active caries, periodontal disease, or ongoing orthodontic treatment

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: Parallel Assignment
  • Masking: None (Open Label)

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: Scigates Toothpaste Group
Participants assigned to this arm will use Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash three times daily for 8 weeks according to standardized instructions.
Drug: Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash
Participants will use Scigates foam mouth sanitizer 2 in 1 toothpaste and mouthwash three times daily for 8 weeks by applying the product directly to the toothbrush and brushing for 2-3 minutes according to standardized instructions.
Active Comparator: Lacalut Toothpaste Group
Participants assigned to this arm will use Lacalut® White & Repair toothpaste three times daily for 8 weeks according to standardized instructions.
Drug: Lacalut White and Repair Toothpaste
Participants will use Lacalut® White and Repair toothpaste three times daily for 8 weeks by applying the product directly to the toothbrush and brushing for 2-3 minutes according to standardized instructions.

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
Reduction in Tooth Sensitivity
Time Frame: Baseline, Week 1, Week 2, Week 4, and Week 8

Tooth sensitivity will be assessed using the Schiff Cold Air Sensitivity Scale. This is a 4-point ordinal scale ranging from 0 to 3, where:

0 = No response to air stimulus (best outcome)

  1. = Response to air stimulus without request to discontinue
  2. = Response with request to discontinue or movement away
  3. = Painful response with request to discontinue (worst outcome)

Interpretation: Lower scores indicate less tooth sensitivity (better outcome), while higher scores indicate greater sensitivity (worse outcome).

Assessments will be performed at Baseline, Week 1, Week 2, Week 4, and Week 8.
Baseline, Week 1, Week 2, Week 4, and Week 8
Reduction in Dental Extrinsic Staining
Time Frame: Baseline, Week 1, Week 2, Week 4, and Week 8

Dental extrinsic staining will be assessed using the Modified Lobene Stain Index (MLSI). This index evaluates both extent and intensity of staining, each scored on a scale from 0 to 3:

Extent of Staining (0-3):

0 = No stain

  1. = Up to 1/3 of surface stained
  2. = 1/3 to 2/3 of surface stained
  3. = More than 2/3 of surface stained

Intensity of Staining (0-3):

0 = No stain

  1. = Light stain
  2. = Moderate stain
  3. = Heavy stain

Scores from extent and intensity (for specified teeth) are summed to generate a composite score, with a possible range from 0 to 12.

Interpretation: Lower scores indicate less staining (better outcome), while higher scores indicate more severe staining (worse outcome).

Stain assessment will be performed on the labial surface of the upper left central incisor and upper left canine (or right counterparts if needed) at Baseline, Week 1, Week 2, Week 4, and Week 8.
Baseline, Week 1, Week 2, Week 4, and Week 8

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.
Prof. Mayyas Al-Remawi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dr. Raed Alkhatib Dental Center
The Jordan Center for Pharmaceutical Research (JCPR)

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.
August 18, 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.
August 31, 2025

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.
August 31, 2025

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).
March 28, 2026

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.
March 28, 2026

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.
April 6, 2026

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.
April 14, 2026

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 9, 2026

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, 2026

More Information

Terms related to this study

Keywords

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.
  • MD-644/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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