Clinical trial NCT05024669: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sensitivity
Keywords: Gluma
Sheildforce Plus
Telio CS
Desensitisers
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2021-08-27
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Within 24 hours
measure: 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.
timeFrame: After one week
measure: 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.
timeFrame: after one month
Secondary outcomes:
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Harisha Dewan
Study officials:
affiliation: University of Jazan
name: Harisha Dewan
role: PRINCIPAL_INVESTIGATOR
References: