Bimaxillary ProclinationNCT04578704
Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
A study testing Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer in people with Bimaxillary Proclination, run by University of Malaya at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bimaxillary Proclination
- What is being tested?
- Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Sep 2019to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Dr. Nurulhuda Maskim, BDS contact
Malaysia1 site, 1 recruiting
- Recruiting
Faculty of Dentistry University of Malaya
Petaling Jaya, Kuala Lumpur, 50603
Dr Norhidayah@Nor Zahidah Mohd Tahir, Morth, 0172630703, norhidayahmt@um.edu.my
About this study
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.
Read the 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
- To measure the post treatment dental and soft tissue stability in the retention phase up to one-year post treatment
- To compare the effectiveness the different types of retainers to maintain the stability of orthodontically corrected bimaxillary proclination
- 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
- Bimaxillary Proclination
- Being tested
- Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer
- Keywords
- stability, retainers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainerOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Vacuum formed retainer group | Experimental | It will be constructed following manufacturer's instructions for the thickness. Receives: 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. Receives: 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. Receives: Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post debond of orthodontic fixed appliances
Secondary outcomes (4)
Stability: Soft tissue changes
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).
Measured: 1 year post debond of orthodontic fixed appliances
Stability of dentition
Any irregularity at lower labial segment will be measured using Little Irregularity Index. This will be measured in millimeter (mm).
Measured: 1 year post debond of orthodontic fixed appliances
Changes in arches parameters
Intra arch changes will be measure based on intermolar width, intercanine width, arch length, overbite and overjet. This will be measured in millimeter (mm).
Measured: 1 year post debond of orthodontic fixed appliances
Impact of retainers on Oral Health Related Quality of Life
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.
Measured: 1 year post debond of orthodontic fixed appliances
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start10 Sep 2019
- Primary completionOct 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bimaxillary ProclinationStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhidayah Mohd Tahir, University of Malaya
- Investigators
- Dr.Norhidayah@Nor Zahidah Mohd Tahir, MOrth, Principal investigator, Faculty of Dentistry University of Malaya Kuala Lumpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578704
- Sponsor's protocol ID
- Bimaxillary Proclination
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2591485Ab 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.
PubMed 26877981Keating 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.
PubMed 3465369Shawesh 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.
PubMed 19797411Thickett 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.
PubMed 19828592Gill 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.
PubMed 17902334Maskim 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.
PubMed 39912971
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04578704
- Acronym / sponsor ID
- Bimaxillary Proclination
- Conditions
- Bimaxillary Proclination
- Keywords
- stability, retainers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To measure the post treatment dental and soft tissue stability in the retention phase up to one-year post treatment
- To compare the effectiveness the different types of retainers to maintain the stability of orthodontically corrected bimaxillary proclination
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Vacuum formed retainer group | Experimental | Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainerIt will be constructed following manufacturer's instructions for the thickness. |
| Fixed bonded retainer group | Experimental | Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainerfixed bonded wire will be bonded on individual tooth extended distal to extraction space that were previously closed by fixed appliances treatment. |
| Vacuum formed retainer and fixed bonded retainer | Experimental | Other: Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainerDouble regime retainer that will be consisted of bonded retainer and vacuum formed retainer for upper and lower arch. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainerPatients 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). | Other | Fixed bonded retainer group, Vacuum formed retainer and fixed bonded retainer, Vacuum formed retainer group |
Primary outcome
Stability: Change in the incisal inclinations
Time frame: 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.
4 secondary outcomes
Stability: Soft tissue changes
Time frame: 1 year post debond of orthodontic fixed appliances
Stability of dentition
Time frame: 1 year post debond of orthodontic fixed appliances
Changes in arches parameters
Time frame: 1 year post debond of orthodontic fixed appliances
Impact of retainers on Oral Health Related Quality of Life
Time frame: 1 year post debond of orthodontic fixed appliances
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Results publication: PubMed 2591485Lew 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.
- Results publication: PubMed 26877981Ab 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.
- Results publication: PubMed 3465369Keating 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.
- Results publication: PubMed 19797411Shawesh 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.
- Results publication: PubMed 19828592Thickett 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.
- Results publication: PubMed 17902334Gill 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.
- Derived from this study: PubMed 39912971Maskim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nurulhuda Maskim, BDS contact
Dr.Norhidayah@Nor Zahidah Mohd Tahir, MOrth principal investigator
Faculty of Dentistry University of Malaya Kuala Lumpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer in people with Bimaxillary Proclination, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Norhidayah Mohd Tahir, MOrth (+603 79674802 ext. 4883, norhidayahmt@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability: Change in the incisal inclinations (time frame: 1 year post debond of orthodontic fixed appliances). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578704, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.