Orthodontic Appliance ComplicationNCT06502886
Evaluation of The Stability of Orthodontic Treatment After First Premolar Extraction Using Combined Retention Protocol
A study testing combined protocol of retention (bonded lingual retainer and vacuum formed retainers) and Bonded lingual retainer in people with Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between the stability of anterior and posterior segments in both arches using bonded lingual retainers versus a combined protocol of retention (bonded lingual retainer and vacuum formed retainers). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- combined protocol of retention (bonded lingual retainer and vacuum formed retainers) and Bonded lingual retainer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2024to 1 Mar 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients at the end of comprehensive orthodontic treatment after extraction of upper and lower first premolars and requiring subsequent application of a lingual and palatal bonded retainers
- Good oral hygiene
- Patients whom the pre-treatment records (models) are available
- Good finishing criteria (ABO grading system)
Who cannot join
- Non-extraction orthodontic treatment
- Poor oral hygiene
- Dental/congenital anomalies ex: Missing laterals, transposed canines, Cleft lip and palate/craniofacial syndromes
- Poor finishing criteria (ABO grading system)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral and dental medicine, Cairo university
Cairo, 11553
Orthodontic Department, 0020223638755, ortho@dentistry.cu.edu.eg
Abdelaziz Taha Malek
About this study
Official title: Evaluation of The Stability of Orthodontic Treatment After First Premolar Extraction in Adult Patients Using Bonded Retainer Versus Bonded Retainer Combined With Vacuum Formed Retainer : A Randomized Clinical Trial
The aim of this study is to compare between the stability of anterior and posterior segments in both arches using bonded lingual retainers versus a combined protocol of retention (bonded lingual retainer and vacuum formed retainers). The effect of different treatment changes achieved on the post-treatment stability will be studied in both groups.
Hypothesis: No difference between BR and BR+VFR regarding the stability of anterior segment alignment and posterior segment alignment and interdigitation
Read the detailed description
Retention is necessary to be done after orthodontic treatment. It aids to prevent the tendency for relapse of teeth toward their pretreatment position. Fixed or removable retention appliances can reduce the risk of relapse, but to date there is still limited evidence on treatment protocols, wearing time and duration. However, long-term retention with bonded lingual retainers is commonly recommended and often considered the gold standard (method of first choice) in orthodontic retention. Regardless of the expected benefits concerning tooth stabilization, aesthetic appearance and independency from the patient's compliance, there have been increasing numbers of reports on undesirable changes in tooth position in the presence of retainers. Since "active" lingual retainers are able to exert forces to teeth, they have been suspected of causing torque changes of adjacent incisors ("X-effect"). Therefore, several authors recommend to insert removable and fixed in both arches for maximum relapse prevention.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- combined protocol of retention (bonded lingual retainer and vacuum formed retainers), Bonded lingual retainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined protocol of retention (bonded lingual retainer and vacuum formed retainers)Procedure or surgery
Also called Fixed lingual retainer and vacuum formed retainer
Combined bonded retainer and vacuum formed retainer
Bonded lingual retainerProcedure or surgery
Also called Fixed lingual retainer
Bonded retainer
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | Use bonded retainer combined with vacuum formed retainer Receives: Procedure: combined protocol of retention (bonded lingual retainer and vacuum formed retainers) |
| The comparator group | Active comparator | Use bonded retainer Receives: Procedure: Bonded lingual retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular anterior segment alignment
Using 3D models, mandibular anterior segment alignment will be measured by little irregularity index
Measured: 6 months
Secondary outcomes (1)
Maxillary anterior segment alignment
Using 3D models, maxillary anterior segment alignment will be measured by little irregularity index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start10 Mar 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelaziz Taha Abdelaziz Malek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502886
- Sponsor's protocol ID
- ORTH 3-3-10
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the members of the research team will have access to the study data. All the data will be secured to maintain confidentiality. No other parties are allowed to assess the results until the study is terminated and the conclusions are revealed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Stability of Orthodontic Treatment After First Premolar Extraction in Adult Patients Using Bonded Retainer Versus Bonded Retainer Combined With Vacuum Formed Retainer : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06502886
- Acronym / sponsor ID
- ORTH 3-3-10
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 16 Jul 2024 (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 aim of this study is to compare between the stability of anterior and posterior segments in both arches using bonded lingual retainers versus a combined protocol of retention (bonded lingual retainer and vacuum formed retainers). The effect of different treatment changes achieved on the post-treatment stability will be studied in both groups.
Hypothesis: No difference between BR and BR+VFR regarding the stability of anterior segment alignment and posterior segment alignment and interdigitation
Detailed description
Retention is necessary to be done after orthodontic treatment. It aids to prevent the tendency for relapse of teeth toward their pretreatment position. Fixed or removable retention appliances can reduce the risk of relapse, but to date there is still limited evidence on treatment protocols, wearing time and duration. However, long-term retention with bonded lingual retainers is commonly recommended and often considered the gold standard (method of first choice) in orthodontic retention. Regardless of the expected benefits concerning tooth stabilization, aesthetic appearance and independency from the patient's compliance, there have been increasing numbers of reports on undesirable changes in tooth position in the presence of retainers. Since "active" lingual retainers are able to exert forces to teeth, they have been suspected of causing torque changes of adjacent incisors ("X-effect"). Therefore, several authors recommend to insert removable and fixed in both arches for maximum relapse prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Procedure: combined protocol of retention (bonded lingual retainer and vacuum formed retainers)Use bonded retainer combined with vacuum formed retainer |
| The comparator group | Active comparator | Procedure: Bonded lingual retainerUse bonded retainer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients at the end of comprehensive orthodontic treatment after extraction of upper and lower first premolars and requiring subsequent application of a lingual and palatal bonded retainers
- Good oral hygiene
- Patients whom the pre-treatment records (models) are available
- Good finishing criteria (ABO grading system)
Key exclusion criteria (4 listed)
- Non-extraction orthodontic treatment
- Poor oral hygiene
- Dental/congenital anomalies ex: Missing laterals, transposed canines, Cleft lip and palate/craniofacial syndromes
- Poor finishing criteria (ABO grading system)
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 |
|---|---|---|
| combined protocol of retention (bonded lingual retainer and vacuum formed retainers)Also: Fixed lingual retainer and vacuum formed retainerCombined bonded retainer and vacuum formed retainer | Procedure or surgery | The intervention group |
| Bonded lingual retainerAlso: Fixed lingual retainerBonded retainer | Procedure or surgery | The comparator group |
Primary outcome
Mandibular anterior segment alignment
Time frame: 6 months
Using 3D models, mandibular anterior segment alignment will be measured by little irregularity index
1 secondary outcome
Maxillary anterior segment alignment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No. All the members of the research team will have access to the study data. All the data will be secured to maintain confidentiality. No other parties are allowed to assess the results until the study is terminated and the conclusions are revealed.
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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.
Faculty of oral and dental medicine, Cairo university
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined protocol of retention (bonded lingual retainer and vacuum formed retainers) and Bonded lingual retainer in people with Orthodontic Appliance Complication, 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 4 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 16 Jul 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular anterior segment alignment (time frame: 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 16 Jul 2024.