Comparative Assessment of Failure Rate of Fixed Lingual Retainer Between Two Types of Light Cured Resin Composite

January 1, 2023 updated by: Mohamed Mohamed Saied, Cairo University

Comparative Assessment of Failure Rate of Fixed Lingual Retainer in Finished Orthodontic Cases Between Two Types of Light Cured Resin Composite. A Randomized Clinical Trial

The study will be performed on human subjects with finished orthodontic treatment to see the failure rate(detachment) of fixed lingual retainer between two types of light cure resin composite

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study consists of two groups, the intervention involve performing bonding of fixed lingual retainer with light cured composite Transbond LR which is manufactured specific for the fixed lingual retainer while the control group involve bonding of fixed lingual retainer by light cured composite Transbond XT with follow up every month for 6 month to see the failure rate(detachment) between the two types of composite

Study Type

Interventional

Enrollment (Anticipated)

90

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Cairo unversity ,Faculty of dentistry

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient at the end of an orthodontic treatment requiring the subsequent application of a lingual and palatal fixed retainer
  • good oral hygiene
  • medically free

Exclusion Criteria:

  • Facial trauma
  • onychophagia
  • habit of biting pencils or pens
  • tooth mobility

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: Transbond LR
in finished orthodontic cases a light cured resin composite (Transbond LR) will be added on fixed lingual retainer to see the failure rate (detachment) with follow up every month for 6 months
Other: Transbond LR
cleaning the lingual surface using oil free pumice then apply acid etch 35% phosphoric acid for 20 second then rinse then Transbond LR will be applied directly on the fixed retainer and lingual surface of the teeth then light cured.
Other Names:
  • 3m brand
Active Comparator: Transbond XT
in finished orthodontic cases a light cured resin composite (Transbond XT) will be added on fixed lingual retainer to see the failure rate (detachment) with follow up every month for 6 months
Other: Transbond XT
cleaning the lingual surface using oil free pumice then apply acid etch 35% phosphoric acid for 20 second then rinse then Transbond XT will be applied directly on the fixed retainer and lingual surface of the teeth then light cured.
Other Names:
  • 3m brand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure rate( detachment rate) of fixed lingual retainer
Time Frame: the patient will be inspected after applying the fixed retainer every month for 6 months
measured by inspection of any detachment partial or complete of the fixed lingual retainer
the patient will be inspected after applying the fixed retainer every month for 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Fady Hussein, Assoc. prof, Cairo Unversity

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)

November 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ORTHO 3-3-3

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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