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

NCT04578704 | Unknown

• 1 other identifier: Bimaxillary Proclination
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Bimaxillary Proclination

Keywords

stability; retainers

Outcome Measures

Primary Outcomes (1)

• Stability: Change in the incisal inclinations

  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.

  1 year post debond of orthodontic fixed appliances

Secondary Outcomes (4)

• Stability: Soft tissue changes

  1 year post debond of orthodontic fixed appliances

• Stability of dentition

  1 year post debond of orthodontic fixed appliances

• Changes in arches parameters

  1 year post debond of orthodontic fixed appliances

• Impact of retainers on Oral Health Related Quality of Life

  1 year post debond of orthodontic fixed appliances

Study Arms (3)

Vacuum formed retainer group

EXPERIMENTAL

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

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

Fixed bonded retainer group

EXPERIMENTAL

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

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

Vacuum formed retainer and fixed bonded retainer

EXPERIMENTAL

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

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

Interventions

Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer OTHER

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; Vacuum formed retainer and fixed bonded retainer; Vacuum formed retainer group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry University of Malaya

Petaling Jaya, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (7)

• 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.

  PMID: 2591485 RESULT

• 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.

  PMID: 26877981 RESULT

• 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.

  PMID: 3465369 RESULT

• 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.

  PMID: 19797411 RESULT

• 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.

  PMID: 19828592 RESULT

• 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.

  PMID: 17902334 RESULT

• 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.

  PMID: 39912971 DERIVED

Study Officials

• Dr.Norhidayah@Nor Zahidah Mohd Tahir, MOrth

  Faculty of Dentistry University of Malaya Kuala Lumpur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Norhidayah Mohd Tahir, MOrth

CONTACT

+603 79674802; norhidayahmt@um.edu.my

Dr. Nurulhuda Maskim, BDS

CONTACT

dgd180002@siswa.um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be decided for the type of retention treatment by picking an opaque and sealed envelope. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Norhidayah bt Mohd Tahir, Lecturer

Model Details: 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)

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 8, 2020
• Study Start: September 10, 2019
• Primary Completion: October 1, 2021
• Study Completion: May 1, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)