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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Hadeer A. ElBehery, Bachelor contact

+201064618667

hadeer.elbehery@dentistry.cu.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of Dentistry, Cairo University

    Cairo

    Recruiting

Other trials in Egypt

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.

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 groups in NCT06476574
Study groupRoleWhat they receive
Vacuum-formed retainerExperimentalAn 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.ExperimentalA 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-canineActive comparatorA 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted26 Jun 2024
  2. Study start29 Sep 2023
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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)
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

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.

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