The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration

The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration: A Randomized Controlled Clinical Trial

This study aims to investigate the influence of desensitizing agents on reducing post-operative sensitivity in posterior composite.

Study Overview

• Status: Completed
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Other: Hurriseal desensitizer; Other: Gluma desensitizer

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients having active primary class I carious lesions on vital molar teeth either in the middle or the inner third of dentin in the three quadrants of each patients.
• Teeth having a positive reaction to vitality test (cold test), no signs of pulp inflammation, or spontaneous pain before treatment.
• Preoperative radiographic record of the carious lesions.
• Buccolingual width is no more than half the inter-cuspal distance

Exclusion Criteria:

• Excessive tooth wear due to clenching or abnormal habits.
• Patients with direct occlusal contact by antagonist cusp (traumatic occlusion).
• Patients with periodontal or gingival disease.
• Patients using analgesics and/or anti-inflammatory medicine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Composite with Hurriseal desensitizer	Other: Hurriseal desensitizer; Patients will receive Hurriseal desensitizing agent and universal bond and composite. Cavities will be restored with light-cured composite resin following the application of bonding agent.
Active Comparator: Composite with Gluma Desensitizer	Other: Gluma desensitizer; Patients will receive Gluma desensitizing agent and universal bond and composite. Cavities will be restored with light-cured composite resin following the application of bonding agent.
No Intervention: Composite without desensitizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypersensitivity assessment	Air spray will be applied from a 2-mm distance on to the occlusal for 3 seconds. The severity of patients' pain/sensitivity will be recorded using (0-10) numerical rating scale. The score will be ranged from 0 (No pain) to 10 (maximum pain)	up to 12 months

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Investigators: Principal Investigator: Nessrin Magdy, BDS, Alexandria University; Study Director: Waleed El-Mahy, PhD, Alexandria University; Study Chair: Rania R Afifi, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): August 5, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: 7/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No