Orthodontic RetainerNCT06476574
Retentive Capacity of Bonded Retainer Vs Vacuum-formed and Combined Bonded-vacuum Retainers
A study testing Vacuum-formed retainer, Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. and Lingual bonded retainer from canine-to-canine in people with Orthodontic Retainer and Fixed Orthodontic Retainer, run by Cairo University at 1 site in Egypt.
Trial summary
The main goal is to test the differences between the retentive capacity of fixed retainer, vacuum-formed retainer \& combination of both; and recommend the most effective protocol for retention of lower incisors crowding treated by non-extraction treatment plan The main question is: In patients with lower incisors… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retainer, Fixed Orthodontic Retainer, Orthodontic Relapse
- What is being tested?
- Vacuum-formed retainer, Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. and Lingual bonded retainer from canine-to-canine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Sep 2023to Aug 2024
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients
- Finished non-extraction orthodontic treatment
- Full set of permanent dentition (excluding third molars).
- Good oral hygiene
- No restorations on lower anterior teeth or morphologic crown anomalies.
- Little's irregularity index score 0
Who cannot join
- Systemic disease or drugs affecting periodontal health.
- Smokers
- Poor oral health that precludes orthodontic treatment (presence of caries, active white spots,or periodontal diseases)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
About this study
Official title: Retentive Capacity of Bonded Retainer Versus Vacuum-formed and Combined Bonded-vacuum Retainers: A Randomized Controlled Clinical Trial
The main goal is to test the differences between the retentive capacity of fixed retainer, vacuum-formed retainer \& combination of both; and recommend the most effective protocol for retention of lower incisors crowding treated by non-extraction treatment plan
The main question is: In patients with lower incisors crowding treated by non-extraction treatment plans, what is the difference in retentive capacity between fixed retainer, vacuum formed retainer and combined bonded and vacuum retainers in maintaining corrected lower anterior segment crowding? After enrolment, each participant will have the orthodontic appliance debonded, the adhesive remnant removed and the enamel surface polished. An alginate impression will be taken to be poured into a study model which will be scanned to obtain STL files for digital models. All patients will have periodontal charting and probing depths recorded for the lower anterior segment. According to the randomization, each patient will be assigned to a group to receive the retainer. All patients will be called for follow-up after 1 week, 1 and 3 months.
Read the detailed description
Research objective: Retention is a key part of success of orthodontic treatment. Unless we can maintain the teeth in position after orthodontic treatment, the beneficial results of the treatment can be lost. There are currently many different types, designs and materials of removable and fixed retainers and it is unclear which retainers are the best, and how long they should be used for. There is also little knowledge about the possible adverse effects on the Periodontal health, patients' satisfaction and compliance are better with which type of retainers; and which retainers have the greatest failure rate. The dual retention protocol -combined vacuum and fixed retainers- is widely used among clinicians but without strong evidence on its effectiveness compared to the use of single retainer.
Research procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Orthodontics department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
Inclusion criteria:
- Adult patients
- Finished non-extraction orthodontic treatment
- Full set of permanent dentition (excluding third molars).
- Good oral hygiene
- No restorations on lower anterior teeth or morphologic crown anomalies.
- Little's irregularity index score 0
Exclusion criteria:
- Systemic disease or drugs affecting periodontal health.
- Smokers
- Poor oral health that precludes orthodontic treatment (presence of caries, active white spots, or periodontal diseases).
Interventions:
- Every patient will be examined for any systemic disease or dental hard or soft tissue pathology, and the eligibility for previously mentioned eligibility criteria will be checked.
- The purpose of the study and the details of the intervention and control will be explained for the patient and they will be asked whether they are willing to
- participate in the study and accordingly will sign an informed consent. Post orthodontic treatment records (study models, digital models and intra-oral photos) will be taken for every patient as part of the routine procedure for the treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University. And used as pre-intervention records
Clinical Procedure:
- After taking post-treatment records, every patient will have the orthodontic appliance debonded, the adhesive remnant removed and the enamel surface polished
- An alginate impression will be taken to be poured into a study model.
- Study models will be scanned to obtain STL files for digital models.
- All patients will have periodontal charting and probing depth recorded for the lower anterior segment.
- According to the randomization, each patient will be assigned to a group to receive the retainer.
- All patients will be called for follow-up after 1 week, 1 and 3 months.
Intervention group I:
Vacuum-formed retainer.
- After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done.
- An alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used.
- The retainer will be finished and delivered to the patient.
- The patient will be instructed to wear the retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement; and he will be supplied with a check list to evaluate the compliance and to calculate the wearing hours.
- Another alginate impression will be taken for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (before wearing of the retainer).
Intervention group II:
Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.
- After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done.
- A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used.
- The retainer will be finished and delivered to the patient.
- The patient will be instructed to wear the Vacuum retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the bonded retainer; and will be supplied with a check list to evaluate the compliance and to calculate the wearing hours.
- Another alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (at the same visit of the delivery of the bonded retainer).
Control group III:
Lingual bonded retainer from canine-to-canine.
- After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done.
- A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors.
- The patient will be instructed to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the retainer.
- An alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (at the same visit of the delivery of the bonded retainer).
All the three groups will be called for follow up after 1week T1, 1month T2 and 3 months T3.
At each follow up visit, an alginate impression will be taken to obtain a study cast which will be later scanned to get a digital model and a periodontal chart will be filled to evaluate the periodontal condition; also, the integrity of the retainers will be checked together with the rate of failure or debonding of the fixed retainer which will be recorded.
The compliance chart will be collected and a new one will be supplied.
Outcomes: Relapse, Patient's compliance and satisfaction, Periodontal health, Integrity of the retainer.
- Conditions
- Orthodontic Retainer, Fixed Orthodontic Retainer, Orthodontic Relapse, Essix Retainer, Vacuum-formed Retainer, Dual Retention Protocol
- Being tested
- Vacuum-formed retainer, Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine., Lingual bonded retainer from canine-to-canine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-formed retainerDevice
- After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done.
- An alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used.
- The retainer will be finished and delivered to the patient.
- The patient will be instructed to wear the retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement; and he will be supplied with a check list to evaluate the compliance and to calculate the wearing hours.
- Another alginate impression will be taken for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (before wearing of the retainer).
Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.Device
- A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used \& it will be finished and delivered to the patient.
- The patient will be instructed to wear the Vacuum retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the bonded retainer; and will be supplied with a check list to evaluate the compliance and to calculate the wearing hours.
- Another alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0.
Lingual bonded retainer from canine-to-canineDevice
- After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done.
- A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors.
- The patient will be instructed to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the retainer.
- An alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (at the same visit of the delivery of the bonded retainer).
| Study group | Role | What they receive |
|---|---|---|
| Vacuum-formed retainer | Experimental | An alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used. Receives: Device: Vacuum-formed retainer |
| Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. | Experimental | A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used. Receives: Device: Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. |
| Lingual bonded retainer from canine-to-canine | Active comparator | A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors. Receives: Device: Lingual bonded retainer from canine-to-canine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The stability of the orthodontic treatment result and the degree of relapse from baseline to 6 months
The stability of the orthodontic treatment result and the degree of relapse will be measured by superimposition of the digital model at each time point on the initial model after debonding at T0.
Measured: Relapse will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Secondary outcomes (4)
Patient's compliance
patients' compliance will be evaluated by the check list supplied at each time point for the groups using removable retainers.
Measured: It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Periodontal health
Periodontal health will be monitored by a filling a periodontal chart at each time point to check the probing depth, bleeding on probing and calculus formation on the lingual surface of lower anteriors.
Measured: It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
The integrity of the retainers
The integrity of the retainers will be evaluated based on the rate of fracture/ debonding and loss of the retainer.
Measured: It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Patient's satisfaction
Patients' satisfaction will be evaluated at each follow up visit, the patients in all groups will fill a questionnaire form.
Measured: It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start29 Sep 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Ayman Ahmed El Behery, Cairo University
- Investigators
- Hadeer A. ElBehery, Bachelor, Principal investigator, Cairo UniversityFady H. Fahim, Ass Professor, Study director, Cairo UniversitySally M. Reyad, Lecturer, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476574
- Sponsor's protocol ID
- derosuperstar123
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retentive Capacity of Bonded Retainer Versus Vacuum-formed and Combined Bonded-vacuum Retainers: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06476574
- Acronym / sponsor ID
- derosuperstar123
- Conditions
- Orthodontic Retainer, Fixed Orthodontic Retainer, Orthodontic Relapse, Essix Retainer, Vacuum-formed Retainer, Dual Retention Protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 Jun 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 main goal is to test the differences between the retentive capacity of fixed retainer, vacuum-formed retainer \& combination of both; and recommend the most effective protocol for retention of lower incisors crowding treated by non-extraction treatment plan
The main question is: In patients with lower incisors crowding treated by non-extraction treatment plans, what is the difference in retentive capacity between fixed retainer, vacuum formed retainer and combined bonded and vacuum retainers in maintaining corrected lower anterior segment crowding? After enrolment, each participant will have the orthodontic appliance debonded, the adhesive remnant removed and the enamel surface polished. An alginate impression will be taken to be poured into a study model which will be scanned to obtain STL files for digital models. All patients will have periodontal charting and probing depths recorded for the lower anterior segment. According to the randomization, each patient will be assigned to a group to receive the retainer. All patients will be called for follow-up after 1 week, 1 and 3 months.
Detailed description
Research objective: Retention is a key part of success of orthodontic treatment. Unless we can maintain the teeth in position after orthodontic treatment, the beneficial results of the treatment can be lost. There are currently many different types, designs and materials of removable and fixed retainers and it is unclear which retainers are the best, and how long they should be used for. There is also little knowledge about the possible adverse effects on the Periodontal health, patients' satisfaction and compliance are better with which type of retainers; and which retainers have the greatest failure rate. The dual retention protocol -combined vacuum and fixed retainers- is widely used among clinicians but without strong evidence on its effectiveness compared to the use of single retainer.
Research procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Orthodontics department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
Inclusion criteria:
- Adult patients
- Finished non-extraction orthodontic treatment
- Full set of permanent dentition (excluding third molars).
- Good oral hygiene
- No restorations on lower anterior teeth or morphologic crown anomalies.
- Little's irregularity index score 0
Exclusion criteria:
- Systemic disease or drugs affecting periodontal health.
- Smokers
- Poor oral health that precludes orthodontic treatment (presence of caries, active white spots, or periodontal diseases).
Interventions:
- Every patient will be examined for any systemic disease or dental hard or soft tissue pathology, and the eligibility for previously mentioned eligibility criteria will be checked.
- The purpose of the study and the details of the intervention and control will be explained for the patient and they will be asked whether they are willing to
- participate in the study and accordingly will sign an informed consent. Post orthodontic treatment records (study models, digital models and intra-oral photos) will be taken for every patient as part of the routine procedure for the treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University. And used as pre-intervention records
Clinical Procedure:
- After taking post-treatment records, every patient will have the orthodontic appliance debonded, the adhesive remnant removed and the enamel surface polished
- An alginate impression will be taken to be poured into a study model.
- Study models will be scanned to obtain STL files for digital models.
- All patients will have periodontal charting and probing depth recorded for the lower anterior segment.
- According to the randomization, each patient will be assigned to a group to receive the retainer.
- All patients will be called for follow-up after 1 week, 1 and 3 months.
Intervention group I:
Vacuum-formed retainer.
- After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done.
- An alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used.
- The retainer will be finished and delivered to the patient.
- The patient will be instructed to wear the retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement; and he will be supplied with a check list to evaluate the compliance and to calculate the wearing hours.
- Another alginate impression will be taken for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (before wearing of the retainer).
Intervention group II:
Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.
- After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done.
- A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used.
- The retainer will be finished and delivered to the patient.
- The patient will be instructed to wear the Vacuum retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the bonded retainer; and will be supplied with a check list to evaluate the compliance and to calculate the wearing hours.
- Another alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (at the same visit of the delivery of the bonded retainer).
Control group III:
Lingual bonded retainer from canine-to-canine.
- After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done.
- A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors.
- The patient will be instructed to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the retainer.
- An alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (at the same visit of the delivery of the bonded retainer).
All the three groups will be called for follow up after 1week T1, 1month T2 and 3 months T3.
At each follow up visit, an alginate impression will be taken to obtain a study cast which will be later scanned to get a digital model and a periodontal chart will be filled to evaluate the periodontal condition; also, the integrity of the retainers will be checked together with the rate of failure or debonding of the fixed retainer which will be recorded.
The compliance chart will be collected and a new one will be supplied.
Outcomes: Relapse, Patient's compliance and satisfaction, Periodontal health, Integrity of the retainer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vacuum-formed retainer | Experimental | Device: Vacuum-formed retainerAn alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used. |
| Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. | Experimental | Device: Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used. |
| Lingual bonded retainer from canine-to-canine | Active comparator | Device: Lingual bonded retainer from canine-to-canineA multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult patients
- Finished non-extraction orthodontic treatment
- Full set of permanent dentition (excluding third molars).
- Good oral hygiene
- No restorations on lower anterior teeth or morphologic crown anomalies.
Key exclusion criteria (3 listed)
- Systemic disease or drugs affecting periodontal health.
- Smokers
- Poor oral health that precludes orthodontic treatment (presence of caries, active white spots,or periodontal diseases)
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 |
|---|---|---|
| Vacuum-formed retainer* After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done. * An alginate impression will be taken to be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used. * The retainer will be finished and delivered to the patient. * The patient will be instructed to wear the retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement; and he will be supplied with a check list to evaluate the compliance and to calculate the wearing hours. * Another alginate impression will be taken for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (before wearing of the retainer). | Device | Vacuum-formed retainer |
| Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.* A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors; followed by an alginate impression; the impression will be poured into a working model for fabrication of the Vacuum-formed retainer; 1mm Hard vacuum sheet will be used \& it will be finished and delivered to the patient. * The patient will be instructed to wear the Vacuum retainer night time only and to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the bonded retainer; and will be supplied with a check list to evaluate the compliance and to calculate the wearing hours. * Another alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0. | Device | Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. |
| Lingual bonded retainer from canine-to-canine* After patient finishes orthodontic treatment, the fixed orthodontic appliance will be debonded; finishing and polishing of the enamel surface will be done. * A multistrand rectangular stainless steel retainer wire will be bonded to the lingual surface of the lower anterior teeth, from the canine-to-canine bonded to all six anteriors. * The patient will be instructed to contact us if any damage occurred to the retainers for immediate replacement or rebonding of the detached parts of the retainer. * An alginate impression will be taken (with the bonded retainer in place) for fabrication of the study model which will later be scanned to obtain the digital model at T0; and a periodontal chart will be filled to record the periodontal status at T0 (at the same visit of the delivery of the bonded retainer). | Device | Lingual bonded retainer from canine-to-canine |
Primary outcome
The stability of the orthodontic treatment result and the degree of relapse from baseline to 6 months
Time frame: Relapse will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
The stability of the orthodontic treatment result and the degree of relapse will be measured by superimposition of the digital model at each time point on the initial model after debonding at T0.
4 secondary outcomes
Patient's compliance
Time frame: It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Periodontal health
Time frame: It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
The integrity of the retainers
Time frame: It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Patient's satisfaction
Time frame: It will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
Hadeer A. ElBehery, Bachelor principal investigator
Cairo University
Fady H. Fahim, Ass Professor study director
Cairo University
Sally M. Reyad, Lecturer study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum-formed retainer, Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine. and Lingual bonded retainer from canine-to-canine in people with Orthodontic Retainer and Fixed 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 6 inclusion and 3 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 26 Jun 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?
Contact Hadeer A. ElBehery, Bachelor (+201064618667, hadeer.elbehery@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The stability of the orthodontic treatment result and the degree of relapse from baseline to 6 months (time frame: Relapse will be measured at 1 week, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner). 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 26 Jun 2024.