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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05882760
Other study ID # LUMHS/REC/-29
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Liaquat University of Medical & Health Sciences
Contact Priya Rani, BDS
Phone 03365179755
Email priya.harjani@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Institute of Dentistry, Liaquat University of Medical and Health Sciences Hyderabad Sindh

Sponsors (1)

Lead Sponsor Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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