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

NCT ID: NCT05024669

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2021-05-10

Brief Summary

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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

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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.

Conditions

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Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Group

where no desensitizer application was done,

Group Type NO_INTERVENTION

No interventions assigned to this group

Group GL

applied with Gluma dentin desensitizer

Group Type EXPERIMENTAL

Gluma desensitiser

Intervention Type COMBINATION_PRODUCT

Gluma desensitiser was used before restoration.

Group SF

applied with Shieldforce desensitizer

Group Type EXPERIMENTAL

Sheildforce Plus desensitiser

Intervention Type COMBINATION_PRODUCT

Sheildforce Plus desensitiser was used before restoration.

Group TC

applied with Telio CS desensitizer

Group Type EXPERIMENTAL

Telio CS desensitiser

Intervention Type COMBINATION_PRODUCT

Telio CS desensitiser was used before restoration.

Interventions

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Gluma desensitiser

Gluma desensitiser was used before restoration.

Intervention Type COMBINATION_PRODUCT

Sheildforce Plus desensitiser

Sheildforce Plus desensitiser was used before restoration.

Intervention Type COMBINATION_PRODUCT

Telio CS desensitiser

Telio CS desensitiser was used before restoration.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jazan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr Harisha Dewan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harisha Dewan

Role: PRINCIPAL_INVESTIGATOR

University of Jazan

Locations

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Harisha Dewan

Jizan, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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Harisha

Identifier Type: -

Identifier Source: org_study_id

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