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

• Sponsor: Nourhan M.Aly (Other)
• Overall Status: Completed
• CT.gov ID: NCT06113874
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dentin Hypersensitivity	Other: Hurriseal desensitizer; Other: Gluma desensitizer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration: A Randomized Controlled Clinical Trial
• Actual Study Start Date: Jul 5, 2022
• Actual Primary Completion Date: Aug 5, 2023
• Actual Study Completion Date: Aug 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hypersensitivity assessment [up to 12 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nourhan M.Aly, Assistant Lecturer of Dental Public Health, University of Alexandria
• ClinicalTrials.gov Identifier: NCT06113874
• Other Study ID Numbers: 7/22
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dentin Sensitivity; Hypersensitivity

Study Results

No Results Posted as of Nov 2, 2023