Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial

University of Malaya

Status: Unknown

Conditions: Bimaxillary Proclination

Treatments: Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer

Study type: Interventional

Funder types: Other

Identifiers

NCT04578704

Bimaxillary Proclination

Details and patient eligibility

About

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.

Full 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

Enrollment: 27 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Pretreatment bimaxillary proclination patients with interincisal angle less than 125º (Keating PJ 1986).
2. Patients with fixed orthodontic appliances treatment on both arches consisting of the extraction of 4 premolars (Keating 1986).
3. Both arches are indicated for retainers.
4. Pre-treatment lateral cephalometric radiograph of adequate diagnostic quality.

Exclusion criteria

1. Pretreatment spacing eg: Median diastema.
2. No change or proclined lower labial segment post treatment.
3. Early debond patient.
4. Patient intended to relocate within study period.
5. Hypodontia that require prosthesis, cleft lip and/or cleft palate, or orthognathic cases.
6. Patients with learning disabilities and unable to listen, speak and read written instructions in Bahasa Melayu or English.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 3 patient groups

Vacuum formed retainer group

Experimental group

Description:

It will be constructed following manufacturer's instructions for the thickness.

Treatment:

Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer

Fixed bonded retainer group

Experimental group

Description:

fixed bonded wire will be bonded on individual tooth extended distal to extraction space that were previously closed by fixed appliances treatment.

Treatment:

Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer

Vacuum formed retainer and fixed bonded retainer

Experimental group

Description:

Double regime retainer that will be consisted of bonded retainer and vacuum formed retainer for upper and lower arch.

Treatment:

Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer