Comparative Assessment of Failure Rate of Fixed Lingual Retainer Between Two Types of Light Cured Resin Composite
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 13, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJanuary 4, 2023
January 1, 2023
9 months
December 13, 2022
January 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Failure rate( detachment rate) of fixed lingual retainer
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
Study Arms (2)
Transbond LR
EXPERIMENTALin 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
Transbond XT
ACTIVE COMPARATORin 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient at the end of an orthodontic treatment requiring the subsequent application of a lingual and palatal fixed retainer
- good oral hygiene
- medically free
You may not qualify if:
- Facial trauma
- onychophagia
- habit of biting pencils or pens
- tooth mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo unversity ,Faculty of dentistry
Cairo, Egypt
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Fady Hussein, Assoc. prof
Cairo unversity
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
December 13, 2022
First Posted
December 21, 2022
Study Start
November 1, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
January 4, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share