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

Primary Purpose

Sensitivity, Tooth

Status
Recruiting
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Tetric N Bond Universal®
Self Etch Tetric N Bond Universal®
GC Fuji IX, GC, Japan®
Activa TM Bioactive Restorative ®
Sponsored by
Liaquat University of Medical & Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensitivity, Tooth

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Dentistry, Liaquat University of Medical and Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Tetric N Bond Universal®

Self Etch Tetric N Bond Universal®

GC Fuji IX, GC, Japan®

Activa TM Bioactive Restorative ®

Arm Description

Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Etch & Rinse Technique using 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®.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2023
Last Updated
June 25, 2023
Sponsor
Liaquat University of Medical & Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05882760
Brief Title
Postoperative Sensitivity Following Placement With Different Restorative Materials In Vital Posterior Teeth
Acronym
GCP
Official Title
Comparison Of Postoperative Sensitivity Following Placement With Different Restorative Materials In Vital Posterior Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity, Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tetric N Bond Universal®
Arm Type
Experimental
Arm Description
Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Etch & Rinse Technique using Tetric N Bond Universal®.
Arm Title
Self Etch Tetric N Bond Universal®
Arm Type
Active Comparator
Arm Description
Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Technique using Tetric N Bond Universal®.
Arm Title
GC Fuji IX, GC, Japan®
Arm Type
Active Comparator
Arm Description
Cavities in this group will be restored with GC Fuji IX, GC, Japan®
Arm Title
Activa TM Bioactive Restorative ®
Arm Type
Active Comparator
Arm Description
Cavities in this group will be restored with Activa TM Bioactive Restorative ®
Intervention Type
Drug
Intervention Name(s)
Tetric N Bond Universal®
Intervention Description
Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Etch & Rinse Tetric - N - Bond (Ivoclar)
Intervention Type
Drug
Intervention Name(s)
Self Etch Tetric N Bond Universal®
Intervention Description
Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Tetric N Bond Universal®
Intervention Type
Drug
Intervention Name(s)
GC Fuji IX, GC, Japan®
Intervention Description
Cavities will be restored with GC Fuji IX, GC, Japan®
Intervention Type
Drug
Intervention Name(s)
Activa TM Bioactive Restorative ®
Intervention Description
Cavities will be restored with Activa TM Bioactive Restorative ®
Primary Outcome Measure Information:
Title
Post Operative Sensitivity
Description
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.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priya Rani, BDS
Phone
03365179755
Email
priya.harjani@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sarang Suresh, BDS
Phone
03154044802
Email
hotchandanisarang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Rani, BDS
Organizational Affiliation
Liaquat University of Medical and Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Dentistry, Liaquat University of Medical and Health Sciences
City
Hyderabad
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feroze Kalhoro

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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