Evaluation of the Effectiveness of Home-Use Desensitizing Agents on Dentin Hypersensitivity

Dentin Sensitivity Clinical Trial

Official title:

Evaluation of the Effectiveness of Home-Use Desensitizing Agents on Dentin Hypersensitivity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216262
• Other study ID #: TSA-2023-4535
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Çanakkale Onsekiz Mart University
• Contact: Gizem AYAN
• Phone: +905076775047
• Email: gizem.ayan[@]comu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Other:
• Control group
Brushing teeth twice a day for 8 weeks
• Arginine
Brushing teeth twice a day for 8 weeks
• Novamin
Brushing teeth twice a day for 8 weeks
• Propolis
Brushing teeth twice a day for 8 weeks
• Casein Phosphopeptide Amorphous Calcium Phosphate
Following the procedure in the control group, it is applied to the tooth surface once a day for 3 minutes before going to bed at night for 8 weeks
• Potassium Nitrate
Following the procedure in the control group, mouthwash twice a day in the morning and evening for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Çanakkale Onsekiz Mart University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15)	Dentin Hypersensitivity Experience Questionnaire-15 (DHEQ-15) is a 7-point Likert scale form consisting of 15 questions used to evaluate dentin sensitivity, with answers ranging from 'strongly agree' to 'strongly disagree'.	for 8 weeks (initially, 4 weeks and 8 weeks)
Primary	Visual Analogue Scale (VAS)	VAS is a scale in which the individual evaluates the pain level between 0 (no hurt) and 10 (hurts worst).	for 8 weeks (initially, 4 weeks and 8 weeks)
Primary	Schiff Sensitivity Scale	In the evaluation of dentin hypersensitivity, a single dentist will apply air to the cervix of the tooth from a distance of 1 cm for 1 second during a clinical examination and the Schiff Sensitivity Scale score will be determined.; 0: subject does not respond to air stimulus; subject responds to air stimulus but does not request discontinuaiton of stimulus; subject responds to air stimulus and requests discontinuaiton or moves from stimulus; subject responds to the air stimulus, considers stimulus to be painful and requests discontinuaiton of the stimulus	for 8 weeks (initially, 4 weeks and 8 weeks)