Dentine Hypersensitivity Clinical Trial
Official title:
Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes
NCT number | NCT06197555 |
Other study ID # | 2022/138 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | February 20, 2023 |
Verified date | December 2023 |
Source | Altinbas University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dentin hypersensitivity is a common problem in society. Untreated hypersensitivity affects the patient's quality of life, complicates plaque control and increases the risk of caries and periodontal disease. This study aimed to evaluate the clinical efficacy of desensitizing toothpastes containing sodium fluoride, stannous fluoride, nano-hydroxyapatite, 8% arginine and calcium carbonate. Fourty eight patients with at least two teeth with positive responses to air and mechanical stimulus were included in the study and were divided into four groups. Sodium fluoride (Colgate®, Cavity Protection) in group A, stannous fluoride (Oral B® Gum Calm & Sensitivity) in group B, nano-hydroxyapatite (ApaCare®) in group C and 8% arginine and calcium carbonate combination in group D (Colgate® Sensitive Pro- ReliefTM) were used by the patients continuously for 16 weeks. Dentin hypersensitivity, by using VAS and Shiff scores and periodontal parameters were evaluated at baseline, 2nd week, 4th week and last 16th week.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 20, 2023 |
Est. primary completion date | December 24, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Dentin hypersensitivity complaints - Systemically healthy - Not during pregnancy & lactation - No sensitivity treatment in the last 6 months - Forty-eight patients with positive response to VAS and Schiff tests were included. Exclusion Criteria: People who have; - Any systemic disease - Take regular medication for any other reason - Undergone periodontal surgery within the last 6 months, - History of allergy to toothpaste materials, - Active caries, restoration and/or bridge on the sensitive tooth, - Orthodontic appliances, |
Country | Name | City | State |
---|---|---|---|
Turkey | Altinbas University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Altinbas University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypersensitivity Reduction | Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | Baseline, 2nd week, 4th week, 16th week | |
Primary | Hypersensitivity Reduction | The Schiff Scale examiner covers the adjacent teeth on either side of the patient's hypersensitive tooth with his/her fingers. Air from the tip of the dental unit's air-water sprayer is applied to the cervical region of the hypersensitive tooth at a distance of approximately 1 cm for 1 second. The degree of hypersensitivity is scored according to the Schiff cold air sensitivity scale. Scoring :
Score 0: The individual does not respond to the stimulus. Score 1: The individual responds to the stimulus but does not request its termination. Score 2: The individual responds to the stimulus and requests its termination or moves to avoid the stimulus. Score 3: The individual responds to the stimulus, finds the stimulus painful and requests its termination. The pain persists for a few seconds after the stimulus is terminated. |
Baseline, 2nd week, 4th week, 16th week | |
Secondary | Clinical Periodontal Measurements | Probing depths (mm) | Baseline, 16th week | |
Secondary | Clinical Periodontal Measurements | Clinical attachment levels (mm) | Baseline, 16th week | |
Secondary | Clinical Periodontal Measurements | Plaque score (%), | Baseline, 16th week | |
Secondary | Clinical Periodontal Measurements | Bleeding score (%) | Baseline, 16th week |
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