Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth (GCP)

Comparison of Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth

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

Study Overview

• Status: Completed
• Conditions: Sensitivity, Tooth
• Intervention / Treatment: Drug: Tetric N Bond Universal®; Drug: Self Etch Tetric N Bond Universal®; Drug: GC Fuji IX, GC, Japan®; Drug: Activa TM Bioactive Restorative ®

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Hyderabad, Sindh, Pakistan
      • Institute of Dentistry, Liaquat University of Medical and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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®.	Drug: Tetric N Bond Universal®; Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Etch & Rinse Tetric - N - Bond (Ivoclar)
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®.	Drug: Self Etch Tetric N Bond Universal®; Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Tetric N Bond Universal®
Active Comparator: GC Fuji IX, GC, Japan®; Cavities in this group will be restored with GC Fuji IX, GC, Japan®	Drug: GC Fuji IX, GC, Japan®; Cavities 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 ®	Drug: Activa TM Bioactive Restorative ®; Cavities will be restored with Activa TM Bioactive Restorative ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Sensitivity	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.	3 Months

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Investigators: Principal Investigator: Priya Rani, BDS, Liaquat University of Medical and Health Science

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Immune System Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: LUMHS/REC/-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No