Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations
Primary Purpose
Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Gluma desensitiser
Sheildforce Plus desensitiser
Telio CS desensitiser
Sponsored by
About this trial
This is an interventional prevention trial for Sensitivity focused on measuring Gluma, Sheildforce Plus, Telio CS, Desensitisers
Eligibility Criteria
Inclusion Criteria:
The selection criteria:
- Age was 20-45 years.
- Vital teeth, (electric pulp test)
- Apical periodontal ligament space radiographically identified
- The remaining dentin thickness at least 1mm.
Exclusion Criteria:
- Restored, periodontally weak nonvital teeth are excluded.
Sites / Locations
- Harisha Dewan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control Group
Group GL
Group SF
Group TC
Arm Description
where no desensitizer application was done,
applied with Gluma dentin desensitizer
applied with Shieldforce desensitizer
applied with Telio CS desensitizer
Outcomes
Primary Outcome Measures
Effect of application of the desensitisers on post operative sensitivity on the day of composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.
The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth on the day of restoration on taking cold drinks, hot drinks, and sugar.
Effect of application of the desensitisers on post operative sensitivity one week after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.
The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one week after the restoration on taking cold drinks, hot drinks, and sugar.
Effect of application of the desensitisers on post operative sensitivity one month after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.
The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one month after the restoration on taking cold drinks, hot drinks, and sugar.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05024669
Brief Title
Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations
Official Title
Efficacy of Three Commercially Available Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jazan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Composite is one of the common aesthetic restorations used in the dentistry. With the advancements in the biomaterials the application of the composites has broadened. However due to various factors the composites are associated with dental sensitivity. Hence in our study we evaluate and compare the effectiveness of three desensitizing agents in reducing the post-treatment sensitivity for class I composite restoration.
Detailed Description
A double-blind, randomized, controlled clinical trial was conducted in which 80 subjects requiring class I cavity were randomly assigned to 4 groups of 20 patients each: Group C (Control group), Group GL (Gluma group), Group SF (Shield Force Plus group), and Group TC (Telio CS group). The class 1 cavity was prepared and after etching, the desensitizers were applied (except in the control group) and later composite restoration was done. The postoperative pain/sensitivity level was recorded according to the Visual Analogue Scale (VAS) on intake of cold drinks; intake of hot drinks; and intake of sugar for different periods of time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity
Keywords
Gluma, Sheildforce Plus, Telio CS, Desensitisers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
where no desensitizer application was done,
Arm Title
Group GL
Arm Type
Experimental
Arm Description
applied with Gluma dentin desensitizer
Arm Title
Group SF
Arm Type
Experimental
Arm Description
applied with Shieldforce desensitizer
Arm Title
Group TC
Arm Type
Experimental
Arm Description
applied with Telio CS desensitizer
Intervention Type
Combination Product
Intervention Name(s)
Gluma desensitiser
Intervention Description
Gluma desensitiser was used before restoration.
Intervention Type
Combination Product
Intervention Name(s)
Sheildforce Plus desensitiser
Intervention Description
Sheildforce Plus desensitiser was used before restoration.
Intervention Type
Combination Product
Intervention Name(s)
Telio CS desensitiser
Intervention Description
Telio CS desensitiser was used before restoration.
Primary Outcome Measure Information:
Title
Effect of application of the desensitisers on post operative sensitivity on the day of composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.
Description
The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth on the day of restoration on taking cold drinks, hot drinks, and sugar.
Time Frame
Within 24 hours
Title
Effect of application of the desensitisers on post operative sensitivity one week after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.
Description
The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one week after the restoration on taking cold drinks, hot drinks, and sugar.
Time Frame
After one week
Title
Effect of application of the desensitisers on post operative sensitivity one month after the composite restoration on application of different stimuli like (i) Intake of cold drinks; (ii) Intake of hot drinks; and (iii) Intake of sugar.
Description
The patients were given a questionnaire and instructed to record any postoperative pain/sensitivity level according to the Visual Analogue Scale (VAS) for restored tooth one month after the restoration on taking cold drinks, hot drinks, and sugar.
Time Frame
after one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The selection criteria:
Age was 20-45 years.
Vital teeth, (electric pulp test)
Apical periodontal ligament space radiographically identified
The remaining dentin thickness at least 1mm.
Exclusion Criteria:
Restored, periodontally weak nonvital teeth are excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harisha Dewan
Organizational Affiliation
Jazan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harisha Dewan
City
Jazan
ZIP/Postal Code
45142
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan
Learn more about this trial
Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations
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