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

NCT06216262 — Not applicable, Completed, 180 participants, Çanakkale Onsekiz Mart University

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Registry	NCT06216262
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	180 (Actual)
Sponsor	Çanakkale Onsekiz Mart University (Other)
Conditions	Dentin Sensitivity
Interventions	Control group, Arginine, Novamin, Propolis, Casein Phosphopeptide Amorphous Calcium Phosphate, Potassium Nitrate (Other)
Dates	start 2024-03-01, primary completion 2024-08-23, completion 2024-08-23, first posted 2024-01-22, last updated 2024-08-26
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Control group	Active comparator	Other: Control group	1450 ppm fluoride toothpaste
Arginine	Active comparator	Other: Arginine	toothpaste containing arginine
Novamin	Active comparator	Other: Novamin	toothpaste containing novamin
Propolis	Active comparator	Other: Propolis	toothpaste containing propolis
Casein Phosphopeptide Amorphous Calcium Phosphate	Active comparator	Other: Control group; Other: Casein Phosphopeptide Amorphous Calcium Phosphate	Dental cream containing casein phosphopeptide amorphous calcium phosphate
Potassium Nitrate	Active comparator	Other: Control group; Other: Potassium Nitrate	mouthwash containing potassium nitrate

Control group (Other): Brushing teeth twice a day for 8 weeks
Arginine (Other): Brushing teeth twice a day for 8 weeks
Novamin (Other): Brushing teeth twice a day for 8 weeks
Propolis (Other): Brushing teeth twice a day for 8 weeks
Casein Phosphopeptide Amorphous Calcium Phosphate (Other): 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 (Other): Following the procedure in the control group, mouthwash twice a day in the morning and evening for 8 weeks

+Outcome measures

Primary outcomes

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'.
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).
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

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Canakkale Onsekiz Mart University Faculty of Dentistry	Çanakkale	Turkey (Türkiye)

+Publications

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. PMID 31640741
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. PMID 24117696
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. PMID 29369544
Results publication: Ayan G, Msmall i, Ukrainianssmall i, Ukrainianllsmall i, Ukrainian T, Buldur M. Home-use agents in the treatment of dentin hypersensitivity: clinical effectiveness evaluation with different measurement methods. Clin Oral Investig. 2025 Jan 15;29(1):63. doi: 10.1007/s00784-025-06155-1. PMID 39810073