Postoperative Sensitivity Following Placement With Different Restorative Materials In Vital Posterior Teeth

Overview

There is a lack of long-term clinical studies comparing different restorative materials; most of the available studies have only looked at class I cavities or examined post-operative sensitivity in non-caries cervical lesions. The purpose of this study is to measure postoperative sensitivity in clinical settings at 3-month intervals for class 1 and 2 direct posterior restoration

Full Title of Study: “Comparison Of Postoperative Sensitivity Following Placement With Different Restorative Materials In Vital Posterior Teeth”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Outcomes Assessor)
• Study Primary Completion Date: September 30, 2023

Interventions

• Drug: Tetric N Bond Universal®
  • Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Etch & Rinse Tetric – N – Bond (Ivoclar)
• Drug: Self Etch Tetric N Bond Universal®
  • Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Tetric N Bond Universal®
• Drug: GC Fuji IX, GC, Japan®
  • Cavities will be restored with GC Fuji IX, GC, Japan®
• Drug: Activa TM Bioactive Restorative ®
  • Cavities will be restored with Activa TM Bioactive Restorative ®

Arms, Groups and Cohorts

• Experimental: Tetric N Bond Universal®
  • Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Etch & Rinse Technique using Tetric N Bond Universal®.
• Active Comparator: Self Etch Tetric N Bond Universal®
  • Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Technique using Tetric N Bond Universal®.
• Active Comparator: GC Fuji IX, GC, Japan®
  • Cavities in this group will be restored with GC Fuji IX, GC, Japan®
• Active Comparator: Activa TM Bioactive Restorative ®
  • Cavities in this group will be restored with Activa TM Bioactive Restorative ®

Clinical Trial Outcome Measures

Primary Measures

• Post Operative Sensitivity
  • Time Frame: 3 Months
  • Sensitivity will be recorded as present when a patient experienced more pain when the cold stimulus is applied on the restored tooth than on the control tooth is assessed using the modified visual analogue scale to any stimulus (occlusal function, cold/hot water, or sweets) every day by the patient until 7 days, then by the clinician on 7 days, 3 months.

Participating in This Clinical Trial

Inclusion Criteria

Either gender Minimum age 18 years, maximum age 40 years. Class I & II Cavity on maxillary and mandibular 1st and 2nd molars. Vital maxillary and mandibular molar teeth that had occlusal contact with antagonist teeth. Exclusion Criteria:

Irreversible Pulpitis diagnosed clinically and radiographically. Class I & Class II cavity of premolars and third molars Patients taking analgesic prior to treatment. History of allergic reaction to any dental material used in the study. History of parafunctional habits (bruxism and/or clenching) Malocclusion

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Liaquat University of Medical & Health Sciences
• Provider of Information About this Clinical Study
  • Principal Investigator: Sarang Suresh, FCPS Trainee – Liaquat University of Medical & Health Sciences
• Overall Official(s)
  • Priya Rani, BDS, Principal Investigator, Liaquat University of Medical and Health Science
• Overall Contact(s)
  • Priya Rani, BDS, 03365179755, priya.harjani@hotmail.com