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

Last updated: September 30, 2025
Sponsor: Tamil Nadu Dr.M.G.R.Medical University
Overall Status: Completed

Phase

N/A

Condition

Allergy

Allergies & Asthma

Treatment

GLUMA (Kulzer GmbH, Germany) desensitizing agent

Clinical Study ID

NCT04248803
CSICDSR
  • Ages 15-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 occusalinterference in restoration

Study Design

Total Participants: 570
Treatment Group(s): 1
Primary Treatment: GLUMA (Kulzer GmbH, Germany) desensitizing agent
Phase:
Study Start date:
February 06, 2020
Estimated Completion Date:
February 20, 2025

Study 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

Connect with a study center

  • CSI College of Dental Sciences and Research

    Madurai, Tamil Nadu 625 001
    India

    Site Not Available

  • CSI College of Dental Sciences and Research

    Madurai 1264521, Tamil Nadu 1255053 625 001
    India

    Site Not Available

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