Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite

November 21, 2023 updated by: Dr. Geeth Deepika, Tamil Nadu Dr.M.G.R.Medical University

Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations

To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to observe the effect of gluma desensitizer application in controlling the post-treatment sensitivity in posterior occlusal composite restoration in molar teeth using 2 adhesive bonding strategies.

The secondary objective is to evaluate the difference in the post-treatment sensitivity on application of Gluma desensitizer either prior to or after acid etching.

The different adhesive gluma desensitizer application groups are randomly divided into 6 groups,

  1. Total etch control group (No gluma desensitizer application)
  2. Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
  3. Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching
  4. Self etch control group (No gluma desensitizer application)
  5. Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
  6. Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching

Study Type

Interventional

Enrollment (Estimated)

504

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • India
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625 001
        • Recruiting
        • CSI College of Dental Sciences and Research
        • Contact:

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

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Occlusal cavitated caries in maxillary and mandibular first and second molars

Exclusion Criteria:

  • Occlusal caries with axial or proximal extension
  • Teeth with periodontal treatment within last three months
  • Teeth with cracks
  • Teeth to be taken as abutment for prosthesis
  • Patients with psychiatric treatment
  • Patients in orthodontic treatment or going to need orthodontic treatment
  • Patients under dentin hypersensitivity or using desensitizer treatment
  • Patients not willing for post treatment follow up
  • Patients having any other teeth with pain or sensitivity symptoms
  • Caries excavation with pulp exposure and post treatment sensitivity due to occusal interference in restoration

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Total etch control group
No gluma desensitizer application
Experimental: TE - GLUMA application prior to acid etching
TE- Total Etch GLUMA - Desensitizing agent
Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent
GLUMA desensitizer is used to reduce tooth sensitivity
Experimental: TE - GLUMA application after acid etching
TE- Total Etch GLUMA - Desensitizing agent
Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent
GLUMA desensitizer is used to reduce tooth sensitivity
No Intervention: Self etch control group
No gluma desensitizer application
Experimental: SE - GLUMA application prior to acid etching
SE - Self Etch GLUMA - Desensitizing agent
Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent
GLUMA desensitizer is used to reduce tooth sensitivity
Experimental: SE - GLUMA application after acid etching
SE - Self Etch GLUMA - Desensitizing agent
Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent
GLUMA desensitizer is used to reduce tooth sensitivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative sensitivity
Time Frame: 24 hours
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
24 hours
post-operative sensitivity
Time Frame: 48 hours
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
48 hours
post-operative sensitivity
Time Frame: 1 week
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) and cold spray VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative sensitivity - stimulus based ( hot/cold) or spontaneous
Time Frame: 24 hours
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
24 hours
post-operative sensitivity -stimulus based ( hot/cold) or spontaneous
Time Frame: 48 hours
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
48 hours
post-operative sensitivity -stimulus based ( hot/cold) or spontaneous
Time Frame: 1 week
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
1 week

Collaborators and Investigators

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

Sponsor

Tamil Nadu Dr.M.G.R.Medical 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)

February 6, 2020

Primary Completion (Estimated)

February 20, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSICDSR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

from May 2021 to May 2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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