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

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Other: Novamin; Other: Control group; Other: Arginine; Other: Propolis; Other: Casein Phosphopeptide Amorphous Calcium Phosphate; Other: Potassium Nitrate

• Registration Number: NCT06216262
• Lead Sponsor: Çanakkale Onsekiz Mart University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-22
• Study Start: 2024-03-01
• Status Verified: 2024-08
• Primary Completion: 2024-08-23
• Study Completion: 2024-08-23
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novamin	Novamin	toothpaste containing novamin
Casein Phosphopeptide Amorphous Calcium Phosphate	Casein Phosphopeptide Amorphous Calcium Phosphate	Dental cream containing casein phosphopeptide amorphous calcium phosphate
Control group	Control group	1450 ppm fluoride toothpaste
Arginine	Arginine	toothpaste containing arginine
Casein Phosphopeptide Amorphous Calcium Phosphate	Control group	Dental cream containing casein phosphopeptide amorphous calcium phosphate
Propolis	Propolis	toothpaste containing propolis
Potassium Nitrate	Control group	mouthwash containing potassium nitrate
Potassium Nitrate	Potassium Nitrate	mouthwash containing potassium nitrate

Primary Outcome Measures

Name	Time	Method
Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15)	for 8 weeks (initially, 4 weeks and 8 weeks)	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'.
Schiff Sensitivity Scale	for 8 weeks (initially, 4 weeks and 8 weeks)	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; 1. subject responds to air stimulus but does not request discontinuaiton of stimulus; 2. subject responds to air stimulus and requests discontinuaiton or moves from stimulus; 3. subject responds to the air stimulus, considers stimulus to be painful and requests discontinuaiton of the stimulus
Visual Analogue Scale (VAS)	for 8 weeks (initially, 4 weeks and 8 weeks)	VAS is a scale in which the individual evaluates the pain level between 0 (no hurt) and 10 (hurts worst).

Trial Locations

Locations (1)

Canakkale Onsekiz Mart University Faculty of Dentistry; 🇹🇷 Canakkale, Turkey