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

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

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-45

SponsorBeenish Hassan

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Excessive tooth wear due to clenching or abnormal habits.

Traumatic occlusion.

Periodontal or gingival disease.

Patients using analgesics and/or anti-inflammatory medicine.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Active Comparator: Group A (Gluma Desensitizer Group)Active comparator 1 intervention

Group B: Active Comparator: Group B (Control Group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beenish Hassan

Lead sponsor

Margalla Institute of Health Sciences

Sponsor institution

Source ClinicalTrials.gov

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