The Effects of Different Dentin Hypersensitivity Treatment Methods on Quality of Life
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 14, 2021
CompletedMay 14, 2021
May 1, 2021
6 months
May 5, 2021
May 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (3)
Teethmate Desensitizer
ACTIVE COMPARATORTetracalcium phosphate and dicalcium phosphate containing desensitizer
Gluma Desensitizer
ACTIVE COMPARATOR%35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer
Hybrid Bond
ACTIVE COMPARATORSelf-etch adhesive resin
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Not having any systemic disease,
- years and older,
- At least one tooth complaining of dentin hypersensitivity (Schiff score\> 1),
- The acceptance of the volunteers participating in the research.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kırıkkale University Faculty of Dentistry, Department of Restorative Dentistry
Kırıkkale, Yahşihan/Kırıkkale, 71450, Turkey (Türkiye)
Related 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.
PMID: 31640741RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Behiye Esra Özdemir, Res. Assist.
Kırıkkale University Faculty of Dentistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
May 5, 2021
First Posted
May 14, 2021
Study Start
March 4, 2020
Primary Completion
September 4, 2020
Study Completion
March 1, 2021
Last Updated
May 14, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- starting 6 months after publication
- Access Criteria
- Behiye Esra Özdemir
all collected IPD