A Phase 2/3 interventional study of Drug/Agent: Gluma Desensitizer and Drug/Agent: No desensitizer (Control) in Post-operative Sensitivity, Dentin Hypersensitivity and Dental Caries, sponsored by Beenish Hassan. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Beenish Hassan · Phase 2/3, Interventional, and Treatment
-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.
Exclusion Criteria:
Patients receiving Gluma desensitizer followed by universal bonding agent and composite restoration on Class I carious lesions.
Drug: Drug/Agent: Gluma Desensitizer
Patients receiving universal bonding agent and composite restoration without Gluma desensitizer on Class I carious lesions.
Drug: Drug/Agent: No desensitizer (Control)
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.
Also known as: Gluma, Glutaraldehyde/HEMA solution, Dentin desensitizer
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.
Also known as: Control group, Composite restoration without desensitizer
Post-operative sensitivity
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.
Time frame: 3 months
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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