Management of Dentinal Hypersensitivity Using Two Dentifrice Technologies

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.

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