Post-operative Sensitivity in Resin Composites

Not Applicable

Completed

• Conditions: Caries,Dental; Sensitivity, Tooth
• Interventions: Procedure: Group B(Adhesive without nanoparticles); Procedure: Group A(Nano-fortified Adhesive)

• Registration Number: NCT06242184
• Lead Sponsor: Pakistan Institute of Medical Sciences

Brief Summary

This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.

Detailed Description

Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.

Study Timeline

• Study Start: 2023-05-15
• Primary Completion: 2023-11-25
• Study Completion: 2023-11-25
• Study First Submitted: 2024-01-27
• Study First Submitted QC: 2024-01-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• participants with goof general health status
• Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
• Vital and Periodontally sound teeth

Exclusion Criteria

• Patient with Temporomandibular dysfunction
• History of spontaneous pain
• Endodontically treated teeth
• Patient on analgesics within the past two weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (Adhesive without Nanoparticles)	Group B(Adhesive without nanoparticles)	Adhesive without nanoparticles
Group A (Nano-fortified Adhesive)	Group A(Nano-fortified Adhesive)	Titanium dioxide nanoparticles incorporated in dentin adhesive

Primary Outcome Measures

Name	Time	Method
Post-operative sensitivity	One month	Post-operative sensitivity evaluated at follow-up periods: one day, one week, two weeks and one month using Visual Analogue Scale score with the score 0( none) and score 3( severe sensitivity)

Trial Locations

Locations (1)

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University; 🇵🇰 Islamabad, Pakistan