Efficacy of Nanoparticle-incorporated Bonding Agent on Post-restorative Sensitivity

September 9, 2023 updated by: NEHAL AMIR, Pakistan Institute of Medical Sciences

Clinical Efficacy of a Novel Titania Nanoparticle-Reinforced Bonding Agent in Reducing Post-Restorative Sensitivity: A Randomized Clinical Trial

Type of study: Randomized Clinical trial To compare post-restorative sensitivity between titania nanoparticle reinforced bonding agent and bonding agent without nanoparticles in posterior composite restorations.

Participants aged 18 years and above with Class-I and Class-II Carious lesions are allocated in two groups. Group A will undergo composite restoration with Nanoparticles incorporated in bonding agent. Group B will undergo restoration without nanoparticles in bonding agent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study Novel titania nanoparticle reinforced bonding agent will be evaluated for post-restorative sensitivity in composite restorations. Participants following the Inclusion criteria will be allocated in this study by Consecutive non-random sampling technique. Participants will be divided into two groups A and B. After rubber dam isolation, carious lesion will be excavated. In group A, titania nanoparticle reinforced bonding agent will be used for restorative treatment while in group B, Bonding agent without nanoparticles will be used. Post-restorative sensitivity record will be taken at 24 hours, after one week and after one month. Sensitivity will be assessed using Visual analog scale (VAS) mean score.

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, Pakistan Institute of Medical Sciences

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants with good general health
  • Selected teeth should be vital and periodontally healthy
  • Class-I and II with minimal cavity depth of 3mm, not exceeding 5mm
  • Defective previous restorations in need of replacement (secondary caries/fractures)
  • Selected teeth should be in occlusion with natural or prosthetic antagonist and adjacent teeth

Exclusion Criteria:

  • Patients with Temporomandibular disorders
  • Extremely poor oral hygiene status
  • Teeth with very deep carious lesions
  • Teeth with periapical or periodontal pathology
  • Patients taking anti-inflammatory, analgesics or psychotropic drugs
  • History of spontaneous pain
  • Previously root canal treated teeth

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A will receive composite resin restoration with Titania nanoparticle incorporated bonding agent
Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agent
Each group will receive Composite resin restoration for Class-I and Class-II carious lesion. In group A, titania nanoparticle reinforced bonding agent will be used
Experimental: Group B
Group B will receive composite resin restoration without Titania nanoparticle incorporated bonding agent
Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agent
Composite resin restoration without Titania nanoparticle incorporated bonding agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-restorative sensitivity in composite resin restoration
Time Frame: 1 month
Evaluation of bonding agent with titania nanoparticles and without nanoparticles on post-restorative sensitivity using Visual analog scale with scoring from 0 to 10. Score 10 means worst outcomes
1 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, Pakistan Institute of Medical Sciences

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)

January 5, 2023

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 9, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOD/ERB/2022/14

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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