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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05660668
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Transbond LR
  • Other: Transbond XT
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Failure rate( detachment rate) of fixed lingual retainer [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo unversity ,Faculty of dentistry Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Mohamed Saied, principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05660668
    Other Study ID Numbers:
    • ORTHO 3-3-3
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 4, 2023