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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04887181
Other study ID # 28/02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 4, 2020
Est. completion date March 1, 2021

Study information

Verified date May 2021
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to evaluate the effects of a self etch adhesive resin and two desensitizing agents(Calcium phosphate, 5% glutaraldehyde) in treatment of dentin hypersensitivity on the quality of life of individuals.


Description:

This in-vivo study was done among 69 participants who reported at least one sensitivite tooth(Schiff Sensitivity Score >1) as a result of the clinical examination. Participants were randomly divided into three treatment groups(n=23): I. Tetracalcium phosphate and dicalcium phosphate containing desensitizer (Teethmate Desensitizer) II. %35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer (Gluma Desensitizer) III. Self-etch adhesive resin (Hybrid Bond) These materials used in treatment of dentin hypersensitivity in 6 months clinical follow-up and the effects on the quality of life of individuals were evaluated with Dentine Hypersensitivity Experience Questionnaire (DHEQ).


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date March 1, 2021
Est. primary completion date September 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Not having any systemic disease, - 18 years and older, - At least one tooth complaining of dentin hypersensitivity (Schiff score> 1), - The acceptance of the volunteers participating in the research. Exclusion Criteria: - Active periodontal disease, - Periodontal surgery for the last 3 months, - Use of desensitizing toothpaste or mouthwash in the last 3 months, - Long-term use of analgesic and anti-inflammatory drugs, - Having a history of allergies, - Women during pregnancy or breastfeeding, - Parafunctional habits (bruxism, teeth grinding etc.), - The presence of caries, pulpitis or restoration in teeth, - Tooth tissue loss due to erosion, abrasion and abfraction, - Congenital anomalies, - Cracked teeth were not included in the study.

Study Design


Intervention

Other:
Teethmate Desensitizer
Powder and liquid contained in the material were mixed. It was applied to the buccal surface of the sensitive tooth. then it was washed away from the tooth surface. 1-4 sessions were applied until the sensitivity disappeared.
Gluma Desensitizer
The material was applied to the buccal surface of the tooth with sensitivity. It was washed with water and removed from the tooth surface. 1-4 sessions were applied until the sensitivity disappeared.
Hybrid Bond
It was applied to the buccal surface of the sensitive tooth with an applicator. It was cured with a LED light device. Dentin sensitivity was checked with evaporative air application. The process was repeated until the sensitivity disappeared.

Locations

Country Name City State
Turkey Kirikkale University Faculty of Dentistry, Department of Restorative Dentistry Kirikkale Yahsihan/Kirikkale

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 Schiff Cold Air Sensitivity Scale Scores Average scores based on Schiff cold air sensitivity scale after evaporative air application. The Schiff score ranges from 0 to 3. Minimum value is 0, maximum value is 3. An increase in the score from 0 to 3 indicates an increase in sensitivity. Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
Primary Visual Analog Scale(VAS) Scores Average scores based on Visual Analog Scale(VAS) after applying evaporative air. The VAS score ranges from 0 to 10. The minimum value is 0 and the maximum value is 10. A score of 0 is defined as "no pain" while a score of 10 is defined as "intolerable pain". Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
Primary Dentin Hypersensitivity Experience Questionnaire (DHEQ) scores Data obtained after individuals complete the Dentin Hypersensitivity Experience Questionnaire. The decrease in the measured scores over time indicates that the quality of life has improved. Change from baseline quality of life at 6 months
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