NCT07511530

Management of Dentinal Hypersensitivity Using Two Dentifrice Technologies

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Prof. Mayyas Al-Remawi · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Dentin Hypersensitivity
• Tooth Discoloration

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-08-18
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2026-04-06
• Last updated: 2026-04-14

Locations

1 site across 1 country: Jordan