Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
NCT ID: NCT07188142
Last Updated: 2025-09-23
Study Results
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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NOT_YET_RECRUITING
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2025-12-01
2026-06-01
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
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.
Active Comparator: Group B (Control Group)
Patients receiving universal bonding agent and composite restoration without Gluma desensitizer on Class I carious lesions.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Traumatic occlusion.
* Periodontal or gingival disease.
* Patients using analgesics and/or anti-inflammatory medicine.
18 Years
45 Years
ALL
No
Sponsors
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Beenish Hassan
OTHER
Responsible Party
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Beenish Hassan
Post Graduate Trainee
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DB/272/25
Identifier Type: -
Identifier Source: org_study_id
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