Orthodontic RetainerNCT05660668
Comparative Assessment of Failure Rate of Fixed Lingual Retainer Between Two Types of Light Cured Resin Composite
A study testing Transbond LR and Transbond XT in people with Orthodontic Retainer, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retainer
- What is being tested?
- Transbond LR and Transbond XT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient at the end of an orthodontic treatment requiring the subsequent application of a lingual and palatal fixed retainer
- good oral hygiene
- medically free
Who cannot join
- Facial trauma
- onychophagia
- habit of biting pencils or pens
- tooth mobility
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Orthodontic Retainer
- Being tested
- Transbond LR, Transbond XT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbond LROther
Also called 3m brand
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.
Transbond XTOther
Also called 3m brand
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Transbond XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate( detachment rate) of fixed lingual retainer
measured by inspection of any detachment partial or complete of the fixed lingual retainer
Measured: the patient will be inspected after applying the fixed retainer every month for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Nov 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic RetainerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Saied, Cairo University
- Investigators
- Fady Hussein, Assoc. prof, Study director, Cairo unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660668
- Sponsor's protocol ID
- ORTHO 3-3-3
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05660668
- Acronym / sponsor ID
- ORTHO 3-3-3
- Conditions
- Orthodontic Retainer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transbond LR | Experimental | Other: Transbond LRin 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 comparator | Other: Transbond XTin 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient at the end of an orthodontic treatment requiring the subsequent application of a lingual and palatal fixed retainer
- good oral hygiene
- medically free
Key exclusion criteria (4 listed)
- Facial trauma
- onychophagia
- habit of biting pencils or pens
- tooth mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transbond LRAlso: 3m brandcleaning 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 | Transbond LR |
| Transbond XTAlso: 3m brandcleaning 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 | Transbond XT |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fady Hussein, Assoc. prof study director
Cairo unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbond LR and Transbond XT in people with Orthodontic Retainer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Saied, BDS (0021003945733, mohamedsaied@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.