NCT05660668

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

December 13, 2022

Last Update Submit

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

EXPERIMENTAL

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

Transbond XT

ACTIVE COMPARATOR

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

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.

Also known as: 3m brand
Transbond LR

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.

Also known as: 3m brand
Transbond XT

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

Cairo unversity ,Faculty of dentistry

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Transbond LRTransbond XT

Study Officials

  • Fady Hussein, Assoc. prof

    Cairo unversity

    STUDY DIRECTOR

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

Locations