Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
- Conditions
- Bimaxillary Proclination
- Interventions
- Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer
- Registration Number
- NCT04578704
- Lead Sponsor
- University of Malaya
- Brief Summary
Bimaxillary dental proclination is the condition where the upper and lower dental arches are procline thus increase lip fullness. Since the aim of orthodontic treatment in bimaxillary proclination in to get flatten profile where the incisor inclinations are purposely reduced or interincisal angle are increased, therefore it is guarded for corrected dentition to maintain stable or not post orthodontic treatment.Therefore, this study is looking into evidence which is the best retainer to maintain stability of bimaxillary proclination cases following fixed appliances treatment.
- Detailed Description
Study title Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
Study Population Pre-treatment of bimaxillary proclination patient who completed active orthodontic treatment with fixed appliances and are scheduled to debond at Orthodontic Clinic, Faculty of Dentistry, University of Malaya.
Study Design Randomized, prospective, single-center control trial. Three parallel arm groups of patients will be assigned for 3 types of retention methods; 1.VFR 2.Fixed bonded retainer 3.Double regime (bonded \& VFR)
Aim of study To determine the best mode of retention to maintain the stability of bimaxillary proclination cases treated by four premolars extraction and fixed appliances.
Specific Objectives
1. To measure the post treatment dental and soft tissue stability in the retention phase up to one-year post treatment
2. To compare the effectiveness the different types of retainers to maintain the stability of orthodontically corrected bimaxillary proclination
3. To determine the impact of the different types of retainers on the OHRQoL
Sample Size The sample size calculation was done using G\*power software version 3.1.The f-test, repeated measures ANOVA, within-between interaction were used.
Based on the effect size of 0.43 (Keating PJ 1986), maximum accuracy (power) of 80% (0.80), error of 5% (0.05), number of groups are 3, number of measurements are 2, correlation among repetitive measures is 0.5, nonsphericity correlation is 1, total number of 18 subjects needed for entire study. Allowing for 50% dropout, a final sample size of 27 subjects with 9 subjects per group will be used.
Study Duration September 2019 - Disember 2021
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 27
- Pretreatment bimaxillary proclination patients with interincisal angle less than 125º (Keating PJ 1986).
- Patients with fixed orthodontic appliances treatment on both arches consisting of the extraction of 4 premolars (Keating 1986).
- Both arches are indicated for retainers.
- Pre-treatment lateral cephalometric radiograph of adequate diagnostic quality.
- Pretreatment spacing eg: Median diastema.
- No change or proclined lower labial segment post treatment.
- Early debond patient.
- Patient intended to relocate within study period.
- Hypodontia that require prosthesis, cleft lip and/or cleft palate, or orthognathic cases.
- Patients with learning disabilities and unable to listen, speak and read written instructions in Bahasa Melayu or English.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vacuum formed retainer and fixed bonded retainer Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer Double regime retainer that will be consisted of bonded retainer and vacuum formed retainer for upper and lower arch. Fixed bonded retainer group Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer fixed bonded wire will be bonded on individual tooth extended distal to extraction space that were previously closed by fixed appliances treatment. Vacuum formed retainer group Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer It will be constructed following manufacturer's instructions for the thickness.
- Primary Outcome Measures
Name Time Method Stability: Change in the incisal inclinations 1 year post debond of orthodontic fixed appliances To measure any changes in the upper incisor to maxillary plane angle, lower incisor to mandibular plane angle and changes in interincisal angle. This angular measurement will be measured in degree.
- Secondary Outcome Measures
Name Time Method Stability: Soft tissue changes 1 year post debond of orthodontic fixed appliances To measure any changes in the nasolabial angle, labiomental angle. These will be measured in degree. The upper and lower lips distances in relation to Rickett's Esthetic line will be measured in millimeter (mm).
Stability of dentition 1 year post debond of orthodontic fixed appliances Any irregularity at lower labial segment will be measured using Little Irregularity Index. This will be measured in millimeter (mm).
Impact of retainers on Oral Health Related Quality of Life 1 year post debond of orthodontic fixed appliances Patients perception towards retainer will be measured using an Oral Health Related Quality of Life (OHIP) questionnaire. Patients will be assessed on how often they experienced the problems mentioned in the questionnaire throughout the time they use the retainers. The scale will be recorded as very often, quite often, sometimes, never, don't know.
Changes in arches parameters 1 year post debond of orthodontic fixed appliances Intra arch changes will be measure based on intermolar width, intercanine width, arch length, overbite and overjet. This will be measured in millimeter (mm).
Trial Locations
- Locations (1)
Faculty of Dentistry University of Malaya
🇲🇾Petaling Jaya, Kuala Lumpur, Malaysia