Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
NCT ID: NCT04578704
Last Updated: 2020-10-08
Study Results
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Basic Information
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UNKNOWN
NA
27 participants
INTERVENTIONAL
2019-09-10
2022-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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)
TREATMENT
DOUBLE
The participants study models will be examined and assigned with a blinding code by first researcher , who will be blinded to the subjects' retainer allocation. Patients name on the printed radiograph will also be removed. Therefore,the first researcher will be blinded to those she will be measuring. The blinding code will be prepared by second researcher before first researcher measure the casts and radiographs.
Study Groups
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Vacuum formed retainer group
It will be constructed following manufacturer's instructions for the thickness.
Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer
Patients will be instructed to wear the removable vacuum form retainer for 8 to 10 hours per day and only removed the retainers during tooth brushing. (Thickett 2010), (Gill 2007).
The vacuum formed retainer will be constructed using thermoplastic material that will be purchased from manufacturer at 1.0mm thickness.
Meanwhile, bonded retainer will be done using Ormco ® response deadsoft retainer wire size 0.190 round, made in USA by ORMCO Corporation, the fixed bonded wire will be extended distal to the extraction spaces that were previously closed by fixed appliances on both the upper and lower arches. The bonded retainer will be wearing by patients for 24 hours.
Double regime retainer that will be comprised of vacuum formed and bonded retainer will be constructed using the same properties as vacuum formed retainer and bonded retainer. A standard oral and written instruction will be given to patients regarding retainer's uses. (Shawesh M et.al, 2009).
Fixed bonded retainer group
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, fixed bonded retainer, vacuum formed and fixed bonded retainer
Patients will be instructed to wear the removable vacuum form retainer for 8 to 10 hours per day and only removed the retainers during tooth brushing. (Thickett 2010), (Gill 2007).
The vacuum formed retainer will be constructed using thermoplastic material that will be purchased from manufacturer at 1.0mm thickness.
Meanwhile, bonded retainer will be done using Ormco ® response deadsoft retainer wire size 0.190 round, made in USA by ORMCO Corporation, the fixed bonded wire will be extended distal to the extraction spaces that were previously closed by fixed appliances on both the upper and lower arches. The bonded retainer will be wearing by patients for 24 hours.
Double regime retainer that will be comprised of vacuum formed and bonded retainer will be constructed using the same properties as vacuum formed retainer and bonded retainer. A standard oral and written instruction will be given to patients regarding retainer's uses. (Shawesh M et.al, 2009).
Vacuum formed retainer and fixed bonded retainer
Double regime retainer that will be consisted of bonded retainer and vacuum formed retainer for upper and lower arch.
Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer
Patients will be instructed to wear the removable vacuum form retainer for 8 to 10 hours per day and only removed the retainers during tooth brushing. (Thickett 2010), (Gill 2007).
The vacuum formed retainer will be constructed using thermoplastic material that will be purchased from manufacturer at 1.0mm thickness.
Meanwhile, bonded retainer will be done using Ormco ® response deadsoft retainer wire size 0.190 round, made in USA by ORMCO Corporation, the fixed bonded wire will be extended distal to the extraction spaces that were previously closed by fixed appliances on both the upper and lower arches. The bonded retainer will be wearing by patients for 24 hours.
Double regime retainer that will be comprised of vacuum formed and bonded retainer will be constructed using the same properties as vacuum formed retainer and bonded retainer. A standard oral and written instruction will be given to patients regarding retainer's uses. (Shawesh M et.al, 2009).
Interventions
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Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer
Patients will be instructed to wear the removable vacuum form retainer for 8 to 10 hours per day and only removed the retainers during tooth brushing. (Thickett 2010), (Gill 2007).
The vacuum formed retainer will be constructed using thermoplastic material that will be purchased from manufacturer at 1.0mm thickness.
Meanwhile, bonded retainer will be done using Ormco ® response deadsoft retainer wire size 0.190 round, made in USA by ORMCO Corporation, the fixed bonded wire will be extended distal to the extraction spaces that were previously closed by fixed appliances on both the upper and lower arches. The bonded retainer will be wearing by patients for 24 hours.
Double regime retainer that will be comprised of vacuum formed and bonded retainer will be constructed using the same properties as vacuum formed retainer and bonded retainer. A standard oral and written instruction will be given to patients regarding retainer's uses. (Shawesh M et.al, 2009).
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Norhidayah Mohd Tahir
Dr.Norhidayah bt Mohd Tahir, Lecturer
Principal Investigators
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Dr.Norhidayah@Nor Zahidah Mohd Tahir, MOrth
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry University of Malaya Kuala Lumpur
Locations
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Faculty of Dentistry University of Malaya
Petaling Jaya, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Maskim N, Mohd Tahir NNZ, Wan Hassan WN. A randomized controlled trial comparing retainers in bimaxillary proclination cases. Clin Oral Investig. 2025 Feb 6;29(2):117. doi: 10.1007/s00784-025-06199-3.
Other Identifiers
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Bimaxillary Proclination
Identifier Type: -
Identifier Source: org_study_id
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