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Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations

NCT07188142 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-23

No results posted yet for this study

Summary

* The aim of this study is to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -Patients visiting OPD will be selected after fulfilment of inclusion criteria. Patients aged 18-45 meeting inclusion criteria and presenting with active primary class I carious lesions on vital molar teeth with ICDAS score 3 will be randomly assigned into two groups: -Group A: Patients will be provided with Gluma desensitizer, Universal Bonding agent and Composite restoration and -Group B: Patients will receive Universal bonding agent and Composite restoration. -The progress of treatment will be followed up immediately (baseline) and at regular follow up visits at 1 week, 1 month and 3 months.
* Post-operative sensitivity will be assessed using an air stimulus and rated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10.

Conditions

  • Post-operative Sensitivity
  • Dentin Hypersensitivity
  • Dental Caries
  • Tooth Sensitivity After Composite Restorations
  • Post-operative Sensitivity After Class I Composite Restorations

Interventions

DRUG

Drug/Agent: Gluma Desensitizer

Gluma desensitizer applied to prepared tooth surface, followed by universal bonding agent and composite restoration. Application done during the first visit of restorative treatment. Post-operative sensitivity measured at baseline, 1 week, 1 month, and 3 months.

DRUG

Drug/Agent: No desensitizer (Control)

Universal bonding agent applied followed by composite restoration without prior use of Gluma desensitizer. Post-operative sensitivity measured at baseline, 1 week, 1 month, and 3 months.

Sponsors & Collaborators

  • Beenish Hassan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-05-01
Completion
2026-06-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188142 on ClinicalTrials.gov