Dentin Hypersensitivity, Tooth Discoloration
Conditions
Keywords
Dentin Hypersensitivity, Tooth Discoloration, Tooth Whitening, Desensitizing Toothpaste, Oral Care Products, Schiff Sensitivity Scale, Lobene Stain Index, Dental Staining
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.
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.
Interventions
DRUGScigates 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.
DRUGLacalut 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.
Sponsors
Prof. Mayyas Al-Remawi
Dr. Raed Alkhatib Dental Center
The Jordan Center for Pharmaceutical Research (JCPR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Tooth Sensitivity | 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. |
| Reduction in Dental Extrinsic Staining | 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. |
Countries
Jordan
Outcome results
None listed