Retentive Capacity of Bonded Retainer Vs Vacuum-formed and Combined Bonded-vacuum Retainers
NCT Number: NCT06476574
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthodontic Retainer|Fixed Orthodontic Retainer|Orthodontic Relapse|Essix Retainer|Vacuum-formed Retainer|Dual Retention Protocol
Interventions: DEVICE: Vacuum-formed retainer|DEVICE: Combined Vacuum-formed and Lingual bonded retainer from canine-to-canine.|DEVICE: Lingual bonded retainer from canine-to-canine
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2023-09-29
Completion Date: 2024-08
Locations: Faculty of Dentistry, Cairo University, Cairo, Egypt

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 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.

Primary Outcome Measures: 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., 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 Outcome Measures: Patient's compliance, patients' compliance will be evaluated by the check list supplied at each time point for the groups using removable retainers., 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., 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., 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., 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