Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug/Agent: Gluma Desensitizer, Drug/Agent: No desensitizer (Control).
- Who it may be relevant to
- Registry conditions: Post-operative Sensitivity, Dentin Hypersensitivity, Dental Caries, Tooth Sensitivity After Composite Restorations. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating the Effects of Two Different Desensitizing Agents on Mitigating Post-Operative Sensitivity Following Composite Restorations - a Randomized Controlled Trial
Overview
* 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.
Detailed description
-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.
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.
Primary outcome measures
- Post-operative sensitivity [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Margalla Institute of Health Sciences Quaid e Azam Avenue, Gulraiz phase 3, Gulraiz Housin — Rawalpindi
Identifiers
NCT: NCT07188142 · DB/272/25