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

NCT05882760 | Completed Phase 4 DMC

• 1 other identifier: LUMHS/REC/-29
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sensitivity, Tooth

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Tetric N Bond Universal®

EXPERIMENTAL

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®

Self Etch Tetric N Bond Universal®

ACTIVE COMPARATOR

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®

GC Fuji IX, GC, Japan®

ACTIVE COMPARATOR

Cavities in this group will be restored with GC Fuji IX, GC, Japan®

Drug: GC Fuji IX, GC, Japan®

Activa TM Bioactive Restorative ®

ACTIVE COMPARATOR

Cavities in this group will be restored with Activa TM Bioactive Restorative ®

Drug: Activa TM Bioactive Restorative ®

Interventions

Tetric N Bond Universal® DRUG

Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Etch \& Rinse Tetric - N - Bond (Ivoclar)

Tetric N Bond Universal®

Self Etch Tetric N Bond Universal® DRUG

Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Tetric N Bond Universal®

Self Etch Tetric N Bond Universal®

GC Fuji IX, GC, Japan® DRUG

Cavities will be restored with GC Fuji IX, GC, Japan®

GC Fuji IX, GC, Japan®

Activa TM Bioactive Restorative ® DRUG

Cavities will be restored with Activa TM Bioactive Restorative ®

Activa TM Bioactive Restorative ®

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead

Study Sites (1)

Institute of Dentistry, Liaquat University of Medical and Health Sciences

Hyderābād, Sindh, Pakistan

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Priya Rani, BDS

  Liaquat University of Medical and Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Trainee

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)