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

Not Applicable

Completed

• Conditions: Sensitivity
• Interventions: Combination Product: Gluma desensitiser; Combination Product: Telio CS desensitiser; Combination Product: Sheildforce Plus desensitiser

• Registration Number: NCT05024669
• Lead Sponsor: University of Jazan

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.

Study Timeline

• Study Start: 2020-12-10
• Primary Completion: 2021-04-10
• Study Completion: 2021-05-10
• Status Verified: 2021-08
• Study First Submitted: 2021-08-14
• Study First Submitted QC: 2021-08-22
• Last Update Submitted: 2021-08-22
• Study First Posted: 2021-08-27
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group GL	Gluma desensitiser	applied with Gluma dentin desensitizer
Group TC	Telio CS desensitiser	applied with Telio CS desensitizer
Group SF	Sheildforce Plus desensitiser	applied with Shieldforce desensitizer

Primary Outcome Measures

Name	Time	Method
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.	Within 24 hours	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.	After one week	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.	after one month	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.

Trial Locations

Locations (1)

Harisha Dewan; 🇸🇦 Jazan, Saudi Arabia