Clinical trial NCT04578704: Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
Official title: Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bimaxillary Proclination
Keywords: stability
retainers
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be encompassed 3 groups of patients that will be assigned for 3 types of retention methods;

1. VFR (upper and lower arches)
2. Fixed bonded retainers (upper and lower arches)
3. Double regime (bonded retainers \& VFR for upper and lower arches). (Abd Rahman 2016)
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Stability: Change in the incisal inclinations
timeFrame: 1 year post debond of orthodontic fixed appliances
Secondary outcomes:
measure: Stability: Soft tissue changes
timeFrame: 1 year post debond of orthodontic fixed appliances
measure: Stability of dentition
timeFrame: 1 year post debond of orthodontic fixed appliances
measure: Changes in arches parameters
timeFrame: 1 year post debond of orthodontic fixed appliances
measure: Impact of retainers on Oral Health Related Quality of Life
timeFrame: 1 year post debond of orthodontic fixed appliances
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Faculty of Dentistry University of Malaya
state: Kuala Lumpur
Study officials:
affiliation: Faculty of Dentistry University of Malaya Kuala Lumpur
name: Dr.Norhidayah@Nor Zahidah Mohd Tahir, MOrth
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lew K. Profile changes following orthodontic treatment of bimaxillary protrusion in adults with the Begg appliance. Eur J Orthod. 1989 Nov;11(4):375-81. doi: 10.1093/oxfordjournals.ejo.a036009.
citation: Ab Rahman N, Low TF, Idris NS. A survey on retention practice among orthodontists in Malaysia. Korean J Orthod. 2016 Jan;46(1):36-41. doi: 10.4041/kjod.2016.46.1.36. Epub 2016 Jan 25.
citation: Keating PJ. The treatment of bimaxillary protrusion. A cephalometric consideration of changes in the inter-incisal angle and soft tissue profile. Br J Orthod. 1986 Oct;13(4):209-20.
citation: Shawesh M, Bhatti B, Usmani T, Mandall N. Hawley retainers full- or part-time? A randomized clinical trial. Eur J Orthod. 2010 Apr;32(2):165-70. doi: 10.1093/ejo/cjp082. Epub 2009 Oct 1.
citation: Thickett E, Power S. A randomized clinical trial of thermoplastic retainer wear. Eur J Orthod. 2010 Feb;32(1):1-5. doi: 10.1093/ejo/cjp061. Epub 2009 Oct 14.
citation: Gill DS, Naini FB, Jones A, Tredwin CJ. Part-time versus full-time retainer wear following fixed appliance therapy: a randomized prospective controlled trial. World J Orthod. 2007 Fall;8(3):300-6.