Management of Dentinal Hypersensitivity Using Two Dentifrice Technologies

NCT07511530 | Completed

• 1 other identifier: MD-644/2021
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dentin Hypersensitivity; Tooth Discoloration

Keywords

Dentin Hypersensitivity; Tooth Discoloration; Tooth Whitening; Desensitizing Toothpaste; Oral Care Products; Schiff Sensitivity Scale; Lobene Stain Index; Dental Staining

Outcome Measures

Primary Outcomes (2)

• Reduction in Tooth Sensitivity

  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

  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

Study Arms (2)

Scigates Toothpaste Group

EXPERIMENTAL

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

Lacalut Toothpaste Group

ACTIVE COMPARATOR

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

Interventions

Lacalut White and Repair Toothpaste DRUG

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.

Lacalut Toothpaste Group

Scigates Foam Mouth Sanitizer 2 in 1 Toothpaste and Mouthwash DRUG

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.

Scigates Toothpaste Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Mayyas Al-Remawi: lead
• Dr. Raed Alkhatib Dental Center: collaborator
• The Jordan Center for Pharmaceutical Research (JCPR): collaborator

Study Sites (1)

University of Petra

Amman, 11196, Jordan

Location

MeSH Terms

Conditions

Dentin Sensitivity; Tooth Discoloration

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University Vice President and Professor of Pharmaceutics and Pharmaceutical Technology

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 6, 2026
• Study Start: August 18, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)