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

Sensitivity, Tooth Clinical Trial

— GCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882760
• Other study ID #: LUMHS/REC/-29
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Sensitivity, Tooth

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