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Completed

NCT Number: NCT04248803

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

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

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Key information

Conditions

Sensitivity, Tooth Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSI College of Dental Sciences and Research

Madurai, Tamil Nadu, 625 001, India

About this study

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,

  • Total etch control group (No gluma desensitizer application)
  • Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
  • Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching
  • Self etch control group (No gluma desensitizer application)
  • Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
  • Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLUMA (Kulzer GmbH, Germany) desensitizing agent

Other

GLUMA desensitizer is used to reduce tooth sensitivity

Primary outcomes

  1. Number of Participants With Post-operative Sensitivity Having VAS Score >3

    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

  2. Number of Participants With Post-operative Sensitivity Having VAS Score >3

    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

  3. Number of Participants With Post-operative Sensitivity Having VAS Score >3

    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

Secondary outcomes

  1. Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3

    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

  2. Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3

    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

  3. Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3

    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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2020
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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