Retentive Capacity of Bonded Retainer Vs Vacuum-formed and Combined Bonded-vacuum Retainers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorCairo University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patients

Finished non-extraction orthodontic treatment

Full set of permanent dentition (excluding third molars).

Good oral hygiene

Disqualifiers

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 design

Design model

Factorial

Treatments tested in this trial

  • Vacuum-formed retainer

    Device

    * 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-canine

    Device

    * 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).

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Vacuum-formed retainerExperimental treatment 1 intervention
Group B: Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.Experimental treatment 1 intervention
Group C: Lingual bonded retainer from canine-to-canineActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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

Secondary outcomes

1

Patient's compliance

patients' compliance will be evaluated by the check list supplied at each time point for the groups using removable 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
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.

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
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.

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
4

Patient's satisfaction

Patients' satisfaction will be evaluated at each follow up visit, the patients in all groups will fill a questionnaire form.

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

Other outcomes

Sponsors and contacts

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