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

August 22, 2021 updated by: Dr Harisha Dewan, University of Jazan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
where no desensitizer application was done,
Experimental: Group GL
applied with Gluma dentin desensitizer
Combination product: Gluma desensitiser
Gluma desensitiser was used before restoration.
Experimental: Group SF
applied with Shieldforce desensitizer
Combination product: Sheildforce Plus desensitiser
Sheildforce Plus desensitiser was used before restoration.
Experimental: Group TC
applied with Telio CS desensitizer
Combination product: Telio CS desensitiser
Telio CS desensitiser was used before restoration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Within 24 hours
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.
Time Frame: 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.
After one week
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.
Time Frame: 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.
after one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jazan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Harisha Dewan, Jazan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Harisha

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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