Clinical trial NCT06216262: Evaluation of the Effectiveness of Home-Use Desensitizing Agents on Dentin Hypersensitivity
Official title: Evaluation of the Effectiveness of Home-Use Desensitizing Agents on Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Arginine
Novamin
Propolis
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dentin sensitivity is one of the most common problems in society and affects the quality of life related to oral health. Agents such as toothpaste, mouthwash, and dental cream are home-type desensitizing agents used as the first step in the treatment of dentin hypersensitivity. A total of 180 individuals with dentin sensitivity will be included in the study and the individuals will be randomly divided into 6 groups. Individuals in the 1st Group will be given arginine-containing toothpaste, individuals in the 2nd Group will be given novamin-containing toothpaste, individuals in the 3rd Group will be given propolis-containing toothpaste, individuals in the 4th Group will be given casein phosphopeptide amorphous calcium phosphate-containing dental cream, and individuals in the 5th Group will be given mouthwash containing potassium nitrate. Classic toothpaste with 1450 ppm fluoride will be distributed to individuals in the control group, which is the 6th group. The Dentin Hypersensitivity Experience Questionnaire (DHEQ-15), consisting of 15 questions, will be used to evaluate dentin sensitivity. Visual Analogue Scale (VAS) will be used to determine the individual's pain score in dentin sensitivity, and the individual will be asked to score the intensity of pain experienced between 0-10 points. Finally, in the evaluation of dentin sensitivity, a single dentist will apply air to the cervix of the tooth from a distance of 1 cm for 1 second, and the Schiff Sensitivity Scale score will be determined through clinical examination. A score between 0 and 3 will be determined by the dentist according to the patient's response to the air stimulus. The effectiveness of the home-use desensitizing agents used in the treatment of dentin hypersensitivity was evaluated with DHEQ-15, VAS and Schiff Sensitivity Scale; Baseline, 4th and 8th week scores will be compared.


Eligibility criteria: Inclusion Criteria:

* Between 18-70 years old
* General health condition is good
* Individuals with sensitivity in 2 or more non-adjacent teeth

Exclusion Criteria:

* Pregnant or breastfeeding women
* Advanced periodontal diseases
* Chronic diseases that may affect the study results
* Major oral pathologies
* Use of anticonvulsant, antihistamine, antidepressant, sedative, tranquilizer medication
* Use of desensitizing paste in the last 3 months
* Individuals who have been treated for periodontal disease in the last 12 months

Primary outcomes:
measure: Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15)
timeFrame: for 8 weeks (initially, 4 weeks and 8 weeks)
measure: Visual Analogue Scale (VAS)
timeFrame: for 8 weeks (initially, 4 weeks and 8 weeks)
measure: Schiff Sensitivity Scale
timeFrame: for 8 weeks (initially, 4 weeks and 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Canakkale
country: Turkey
facility: Canakkale Onsekiz Mart University Faculty of Dentistry
Study officials:
References:
citation: Mason S, Burnett GR, Patel N, Patil A, Maclure R. Impact of toothpaste on oral health-related quality of life in people with dentine hypersensitivity. BMC Oral Health. 2019 Oct 22;19(1):226. doi: 10.1186/s12903-019-0919-x.
citation: Baker SR, Gibson BJ, Sufi F, Barlow A, Robinson PG. The Dentine Hypersensitivity Experience Questionnaire: a longitudinal validation study. J Clin Periodontol. 2014 Jan;41(1):52-9. doi: 10.1111/jcpe.12181. Epub 2013 Nov 6.
citation: Basaran S, Celik C. Turkish Adaptation of Dentine Hypersensitivity Experience Questionnaire (DHEQ). Community Dent Health. 2018 Mar 1;35(1):47-51. doi: 10.1922/CDH_4151Basaran05.