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

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Teethmate Desensitizer
Gluma Desensitizer
Hybrid Bond
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Dentin Hypersensitivity, Desensitizing Agent, Adhesive Resin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kırıkkale University Faculty of Dentistry, Department of Restorative Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Teethmate Desensitizer

Gluma Desensitizer

Hybrid Bond

Arm Description

Tetracalcium phosphate and dicalcium phosphate containing desensitizer

%35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer

Self-etch adhesive resin

Outcomes

Primary Outcome Measures

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.
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".
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.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2021
Last Updated
May 10, 2021
Sponsor
Kırıkkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04887181
Brief Title
The Effects of Different Dentin Hypersensitivity Treatment Methods on Quality of Life
Official Title
The Effects of Different Dentin Hypersensitivity Treatment Methods on Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
September 4, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
Dentin Hypersensitivity, Desensitizing Agent, Adhesive Resin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teethmate Desensitizer
Arm Type
Active Comparator
Arm Description
Tetracalcium phosphate and dicalcium phosphate containing desensitizer
Arm Title
Gluma Desensitizer
Arm Type
Active Comparator
Arm Description
%35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer
Arm Title
Hybrid Bond
Arm Type
Active Comparator
Arm Description
Self-etch adhesive resin
Intervention Type
Other
Intervention Name(s)
Teethmate Desensitizer
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gluma Desensitizer
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hybrid Bond
Intervention Description
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.
Primary Outcome Measure Information:
Title
Schiff Cold Air Sensitivity Scale Scores
Description
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.
Time Frame
Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
Title
Visual Analog Scale(VAS) Scores
Description
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".
Time Frame
Before treatment, immediately after treatment, 1 week, 1 month, 3 month and 6 month
Title
Dentin Hypersensitivity Experience Questionnaire (DHEQ) scores
Description
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.
Time Frame
Change from baseline quality of life at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behiye Esra Özdemir, Res. Assist.
Organizational Affiliation
Kırıkkale University Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırıkkale University Faculty of Dentistry, Department of Restorative Dentistry
City
Kırıkkale
State/Province
Yahşihan/Kırıkkale
ZIP/Postal Code
71450
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
Behiye Esra Özdemir
Citations:
PubMed Identifier
31640741
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.
Results Reference
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The Effects of Different Dentin Hypersensitivity Treatment Methods on Quality of Life

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