NCT04887181

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 5, 2021

Last Update Submit

May 10, 2021

Conditions

Keywords

Dentin HypersensitivityDesensitizing AgentAdhesive Resin

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 COMPARATOR

Tetracalcium phosphate and dicalcium phosphate containing desensitizer

Other: Teethmate Desensitizer

Gluma Desensitizer

ACTIVE COMPARATOR

%35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer

Other: Gluma Desensitizer

Hybrid Bond

ACTIVE COMPARATOR

Self-etch adhesive resin

Other: Hybrid Bond

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.

Teethmate 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.

Gluma Desensitizer

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.

Hybrid Bond

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

gluma desensitizerHybrid Bond

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Behiye Esra Özdemir, Res. Assist.

    Kırıkkale University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

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

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
starting 6 months after publication
Access Criteria
Behiye Esra Özdemir

Locations