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

NCT07188142 | Not Yet Recruiting Phase 2

• 1 other identifier: DB/272/25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

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

Keywords

Post-operative sensitivity; Dentinal hypersensitivity; Class I caries; Gluma desensitizer; Composite restoration

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Active Comparator: Group A (Gluma Desensitizer Group)

ACTIVE COMPARATOR

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

Drug: Drug/Agent: Gluma Desensitizer

Active Comparator: Group B (Control Group)

ACTIVE COMPARATOR

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

Drug: Drug/Agent: No desensitizer (Control)

Interventions

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.

Also known as: Gluma, Glutaraldehyde/HEMA solution, Dentin desensitizer

Active Comparator: Group A (Gluma Desensitizer Group)

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.

Also known as: Control group, Composite restoration without desensitizer

Active Comparator: Group B (Control Group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beenish Hassan: lead

Study Sites (1)

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

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Dentin Sensitivity; Dental Caries

Interventions

Gluma; Control Groups

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Dr. Beenish Hassan

CONTACT

+92 333 9502970; beenishhassan2000@gmail.com

Dr. Sana Jalil Hasan

CONTACT

+92 334 5296968; sanahasanjalil5@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Trainee

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 23, 2025
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)