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

NCT ID: NCT07188142

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-06-01

Brief Summary

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* 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

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-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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Active Comparator: Group A (Gluma Desensitizer Group)

Patients receiving Gluma desensitizer followed by universal bonding agent and composite restoration on Class I carious lesions.

Group Type ACTIVE_COMPARATOR

Drug/Agent: Gluma Desensitizer

Intervention Type 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.

Active Comparator: Group B (Control Group)

Patients receiving universal bonding agent and composite restoration without Gluma desensitizer on Class I carious lesions.

Group Type ACTIVE_COMPARATOR

Drug/Agent: No desensitizer (Control)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Gluma Glutaraldehyde/HEMA solution Dentin desensitizer Control group Composite restoration without desensitizer

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beenish Hassan

OTHER

Sponsor Role lead

Responsible Party

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Beenish Hassan

Post Graduate Trainee

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Dr. Beenish Hassan

Role: CONTACT

+92 333 9502970

Dr. Sana Jalil Hasan

Role: CONTACT

+92 334 5296968

Facility Contacts

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Dr. Beenish Hassan

Role: primary

+92 333 9502970

Other Identifiers

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DB/272/25

Identifier Type: -

Identifier Source: org_study_id

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