Post-operative Sensitivity in Resin Composites

February 3, 2024 updated by: NEHAL AMIR, Pakistan Institute of Medical Sciences

Post-operative Sensitivity in Composites Using Bacillus Subtilis Procured Novel Nano-fortified Adhesive: a Triple-blind Study

This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan
        • School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • participants with goof general health status
  • Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
  • Vital and Periodontally sound teeth

Exclusion Criteria:

  • Patient with Temporomandibular dysfunction
  • History of spontaneous pain
  • Endodontically treated teeth
  • Patient on analgesics within the past two weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Nano-fortified Adhesive)
Titanium dioxide nanoparticles incorporated in dentin adhesive
Procedure: Group A(Nano-fortified Adhesive)
Nano-fortified dentin adhesive
Experimental: Group B (Adhesive without Nanoparticles)
Adhesive without nanoparticles
Procedure: Group B(Adhesive without nanoparticles)
Conventional adhesives without nanoparticles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative sensitivity
Time Frame: One month
Post-operative sensitivity evaluated at follow-up periods: one day, one week, two weeks and one month using Visual Analogue Scale score with the score 0( none) and score 3( severe sensitivity)
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Medical Sciences

Investigators

  • Principal Investigator: Nehal Amir, BDS, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Actual)

November 25, 2023

Study Completion (Actual)

November 25, 2023

Study Registration Dates

First Submitted

January 27, 2024

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAMIR

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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