Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates

November 30, 2022 updated by: Foundation University Islamabad
This randomized clinical trial is aimed to evaluate the bond failure rates of the brackets bonded with nano-hybrid composites (Filtek Z250) to that of conventional composites (Transbond XT)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Orthodontic brackets are attached to the teeth with a robust bonding material called composite resin, however sometimes the bond between the braket and the tooth surface may fail halting the desired tooth movement. Repeated bond failures like these are inconvenience both for the orthodontists as well as the patients. With each bracket loosening due to bond failure, treatment time is prolonged as the activation planned on eash visit is delayed resuling in increased treatment time.

Nanotechnology has recently made a breakthrough in dental materials through incorporation of nanoparticles. Composites containing nano-filler particles exhibit higher compression strength, flexural strength, elastic modulus and wear resistance (Rabia and Bilal). In vitro studies have shown that nanohbrid composites have shear bond stregnths similar to that of conventional composites however the environment of oral cavity is challenging and there are no long term clinical trials to validate these results.

The aim of this study is to compare the rate of bond failure between the brackets bonded with nano hybrid composites and that of the conventional composites over a period of six months.

Study Type

Interventional

Enrollment (Anticipated)

40

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/ Federal
      • Islamabad, Islamabad/ Federal, Pakistan, 45720
        • Foundation University Islamabad

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

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients having treatment with fixed metallic orthodontic appliances
  • Patients in whom both upper and lower arches are bonded in single visit

Exclusion Criteria:

  • Patients with variations in morphology of teeth
  • Patients with defective enamel, dentine and cementum
  • Patiens with parafunctioal habits
  • Patients with restorations involving the facial surface of 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Composite Group (Transbond XT)
Patients in which brackets will be bonded with conventional composite resin (Transbond XT)
Combination product: Conventional Composite Group (Transbond XT)
Patients in which brackets will be bonded with conventional composite resin (Transbond XT)
Experimental: Nanohybrid Compisite Group (Filtek Z250)
Patients in which brackets will be bonded with nanohybrid composite resin (Filtek Z250)
Combination product: Nanohybrid Compisite Group (Filtek Z250)
Orthodontic brackets shall be bonded with Nano hybrid composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bracket failure rate
Time Frame: 6 months
Number of brackets detached from the tooth surface
6 months

Collaborators and Investigators

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

Sponsor

Foundation University Islamabad

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)

September 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Estimate)

December 9, 2022

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • FUI/CTR/2022/19

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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