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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

57

Phase

  • 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

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
Intervention / Treatment
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

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

Prof. Mayyas Al-Remawi

Collaborators

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)

August 18, 2024

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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