The Effects of Different Dentin Hypersensitivity Treatment Methods on Quality of Life

May 10, 2021 updated by: Behiye Esra Özdemir, Kırıkkale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yahşihan/Kırıkkale
      • Kırıkkale, Yahşihan/Kırıkkale, Turkey, 71450
        • Kırıkkale University Faculty of Dentistry, Department of Restorative Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Teethmate Desensitizer
Tetracalcium phosphate and dicalcium phosphate containing desensitizer
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.
Active Comparator: Gluma Desensitizer
%35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer
Other: 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.
Active Comparator: Hybrid Bond
Self-etch adhesive resin
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schiff Cold Air Sensitivity Scale Scores
Time Frame: Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
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
Visual Analog Scale(VAS) Scores
Time Frame: Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
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
Dentin Hypersensitivity Experience Questionnaire (DHEQ) scores
Time Frame: Change from baseline quality of life at 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Investigators

  • Principal Investigator: Behiye Esra Özdemir, Res. Assist., Kırıkkale University faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2020

Primary Completion (Actual)

September 4, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

Behiye Esra Özdemir

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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