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NCT Number: NCT07188142

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

* 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Margalla Institute of Health Sciences Quaid e Azam Avenue, Gulraiz phase 3, Gulraiz Housing Scheme, Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Location contact

Dr. Beenish Hassan

CONTACT

[email protected]

+92 333 9502970

Dr. Beenish Hassan

PRINCIPAL_INVESTIGATOR

About this study

-This randomized clinical trial is done to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -The study sample size includes a total of 60 participants aged 18 to 45, each having two Class I carious lesions requiring composite restorations. -Patients will be randomly divided into two groups using a lottery method: -Group A receiving Gluma desensitizer, universal bonding agent, and composite restoration, and -Group B receiving universal bonding agent and composite restoration without desensitizer. -Patients will be selected from the outpatient dental clinic after fulfilling inclusion criteria, which include age between 18 and 45 years, good oral hygiene, active primary Class I carious lesions on vital molar teeth with an ICDAS score of 3, complaints of sensitivity to air and osmotic stimulus, positive response to cold test, and no signs of pulp inflammation or spontaneous pain before treatment. -Exclusion criteria include excessive tooth wear due to clenching or abnormal habits, traumatic occlusion, periodontal or gingival disease, and current use of analgesics and/or anti-inflammatory medication. -Post-operative sensitivity will be measured clinically using an air stimulus and evaluated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10. ranging from 0 (no sensitivity) to 10 (unbearable sensitivity) at baseline (immediately after treatment) and at 1 week, 1 month, and 3 months postoperatively. -Statistical analysis will be performed using non-parametric tests including the Friedman test for within-group comparisons and Wilcoxon signed-rank test for between-group differences, with significance set at p < 0.05. -This study will further add to the literature by providing clinical evidence regarding the efficacy of Gluma desensitizer in reducing post-operative sensitivity and improving patient comfort following restorative dental procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18-45 years.
  • Good oral hygiene.
  • Active primary class I carious lesions on vital molar teeth with ICDAS score 3
  • Patients complaining of sensitivity to air and osmotic stimulus.
  • Teeth having a positive cold test.
  • No signs of pulp inflammation or spontaneous pain before treatment.

Exclusion criteria

  • Excessive tooth wear due to clenching or abnormal habits.
  • Traumatic occlusion.
  • Periodontal or gingival disease.
  • Patients using analgesics and/or anti-inflammatory medicine.

Treatment and study plan

Drug/Agent: Gluma Desensitizer

Drug

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.

Other names: Gluma, Glutaraldehyde/HEMA solution, Dentin desensitizer

Drug/Agent: No desensitizer (Control)

Drug

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.

Other names: Control group, Composite restoration without desensitizer

Primary outcomes

  1. Post-operative sensitivity

    Time frame: 3 months

    Change in dentinal hypersensitivity following Class I composite restorations, measured using a numeric rating scale to evaluate Post-operative Sensitivity (0-10) (0: No sensitivity, 10: Unbearable sensitivity) in response to air stimulus at baseline, 1 week, 1 month and 3 months post-treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Beenish Hassan

CONTACT

[email protected]

+92 333 9502970

Dr. Sana Jalil Hasan

CONTACT

[email protected]

+92 334 5296968

Sponsors and collaborators

Lead sponsor

Beenish Hassan

Other

Registry information

Official study title

Investigating the Effects of Two Different Desensitizing Agents on Mitigating Post-Operative Sensitivity Following Composite Restorations - a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2025
Registry last updated
Sep 23, 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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