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

Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05024669
• Other study ID #: Harisha
• Status: Completed
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: August 2021
• Source: University of Jazan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 10, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Sensitivity

Intervention

Combination Product:
• Gluma desensitiser
Gluma desensitiser was used before restoration.
• Sheildforce Plus desensitiser
Sheildforce Plus desensitiser was used before restoration.
• Telio CS desensitiser
Telio CS desensitiser was used before restoration.

Locations

Country	Name	City	State
Saudi Arabia	Harisha Dewan	Jazan

Sponsors (1)

Lead Sponsor	Collaborator
University of Jazan

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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