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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05024669
Other study ID # Harisha
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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