Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations

Efficacy of Three Commercially Available Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Sensitivity
• Intervention / Treatment: Combination product: Gluma desensitiser; Combination product: Sheildforce Plus desensitiser; Combination product: Telio CS desensitiser

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jazan, Saudi Arabia, 45142
    • Harisha Dewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; where no desensitizer application was done,
Experimental: Group GL; applied with Gluma dentin desensitizer	Combination product: Gluma desensitiser; Gluma desensitiser was used before restoration.
Experimental: Group SF; applied with Shieldforce desensitizer	Combination product: Sheildforce Plus desensitiser; Sheildforce Plus desensitiser was used before restoration.
Experimental: Group TC; applied with Telio CS desensitizer	Combination product: Telio CS desensitiser; Telio CS desensitiser was used before restoration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 24 hours
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.	After one week
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.	after one month

Collaborators and Investigators

• Sponsor: University of Jazan
• Investigators: Principal Investigator: Harisha Dewan, Jazan University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): April 10, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: August 22, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Gluma; Sheildforce Plus; Telio CS; Desensitisers
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: Harisha

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan

Drug and device information, study documents

• 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