Malocclusion, Angle Class IIINCT03354442
Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance
A study testing Modified Fixed Mandibular Retractor Appliance in people with Malocclusion, Angle Class III, run by Damascus University at 1 site in Syria.
Trial summary
This experimental study aims to evaluate the efficiency of the Modified Fixed Mandibular Retractor Appliance in the treatment of skeletal class III malocclusion. The study sample will consist of 44 patients with skeletal class III malocclusion. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Malocclusion, Angle Class III
- What is being tested?
- Modified Fixed Mandibular Retractor Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSyria
- Study dates
- 15 May 2017to 10 Jan 2019
- 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 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients in early mixed dentation (7-9 years old).
- Skeletal class III caused by mandibular prognathism with or without maxillary deficiency judged clinically and confirmed radiographically (ANB≤1).
- Anterior crossbite on two teeth or more.
- Normal inclination of the lower incisors with the mandibular plane.
- Good oral hygiene.
Who cannot join
- Poor oral hygiene.
- Previous orthodontic treatment.
- Patients with syndromes, clefts, or craniofacial abnormalities.
- Severe skeletal class III resulting primarily from mandibular prognathism (ANB less than - 4 with no functional shift on closure)
- Patients with facial asymmetry.
- Patients with vertical growth pattern.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Modified Fixed Mandibular Retractor Appliance in the Treatment of Class III Malocclusion: A Clinical Randomized Controlled Trial
This experimental study aims to evaluate the efficiency of the Modified Fixed Mandibular Retractor Appliance in the treatment of skeletal class III malocclusion.
The study sample will consist of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly into two groups: experimental group and untreated control group.
The soft and hard tissue changes will be assessed using lateral cephalometric radiographs before the treatment and after obtaining 3mm positive overjet.
Read the detailed description
This research aimes to evaluate the effects of a Class III functional appliance [the modified fixed mandibular retractor (MFMR)] in the early treatment of skeletal Class III deformities.
It was not ethical to expose all candidate children to radiographic examination. Therefore, the assessment of skeletal Class III malocclusion was based on clinical judgment. Each patient was examined, while his/her mandible was kept at its retruded contact position to evaluate both jaws in space. Those who met the inclusion criteria were then sent to the radiographic department.
The radiographic lateral cephalograms were obtained in the patients' habitual occlusion.
All patients in the treatment group were treated by one specialist orthodontist 'AA' using the MFMR. The appliance consisted of the following elements: (1) Two acrylic upper posterior bite planes which cover the deciduous and permanent molars ( 2) Two transpalatal arch (0.8-mm TMA) with opposite U loop, the anterior one is near the first deciduous molars while the posterior one is near the first permanent molars (3) upper reversed labial bow (0.9-mm stainless steel) extending to the cervical edges of the mandibular anterior teeth from the labial surface of the lower primary canine on one side to the other labial surface of the contralateral tooth. This bow will be activated to hold the mandible in its maximum posterior physiologic position; and (4) the anterior spring (0.8-mm TMA) which starts from the acrylic bite plane in both sides, makes loop, then bends to touch the cingulum of upper incisors to procline the upper permanent incisors when diagnosed as retroclined.
The untreated group will receive no orthodontic treatment during the observation period. According to the Dental School Local Research Ethics Committee's guidelines, all children in the untreated group will receive orthodontic treatment after the end of the observational period of the study at no cost.
- Conditions
- Malocclusion, Angle Class III
- Being tested
- Modified Fixed Mandibular Retractor Appliance
- Keywords
- Class III treatment, Modified Fixed Mandibular Retractor Appliance, RCT
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Fixed Mandibular Retractor ApplianceDevice
All patients with Class III malocclusion will be treated using the Modified Fixed Mandibular Retractor Appliance
| Study group | Role | What they receive |
|---|---|---|
| Modified Fixed Mandibular Retractor | Experimental | All patients in this group will be treated using Modified Fixed Mandibular Retractor Appliance. This appliance will be used full-time. Receives: Device: Modified Fixed Mandibular Retractor Appliance |
| Untreated control group | No intervention | All patients in this group will be observed during the period of treating the patients in the other group to assess the growth changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANB angle changes
ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Measured: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Secondary outcomes (5)
SNA angle changes
SNA angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Measured: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
SNB angle changes
SNB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Measured: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Profile changes
Profile changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Measured: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Upper incisor angle changes
Upper incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Measured: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Lower incisor angle changes
Lower incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Measured: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start15 May 2017
- Primary completion20 Dec 2017
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIIStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad S Burhan, PhD., Study chair, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354442
- Sponsor's protocol ID
- UDDS-Ortho-08-2017
- Status last verified
- Jul 2019
- First submitted
- 15 Nov 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
Publications
Alhaija ES. Skeletal, dental and soft tissue changes in postural class III malocclusion treated with a maxillary removable appliance. J Clin Pediatr Dent. 2006 Winter;31(2):149-52. doi: 10.17796/jcpd.31.2.u286433up81kt472.
PubMed 17315814Akin M, Ucar FI, Chousein C, Sari Z. Effects of chincup or facemask therapies on the orofacial airway and hyoid position in Class III subjects. J Orofac Orthop. 2015 Nov;76(6):520-30. doi: 10.1007/s00056-015-0315-3.
PubMed 26446505Majanni AM, Hajeer MY. The Removable Mandibular Retractor vs the Bone-anchored Intermaxillary Traction in the Correction of skeletal class III Malocclusion in children: A Randomized Controlled Trial. J Contemp Dent Pract. 2016 May 1;17(5):361-71. doi: 10.5005/jp-journals-10024-1856.
PubMed 27443361Seehra J, Fleming PS, Mandall N, Dibiase AT. A comparison of two different techniques for early correction of Class III malocclusion. Angle Orthod. 2012 Jan;82(1):96-101. doi: 10.2319/032011-197.1. Epub 2011 Aug 1.
PubMed 21806467Atalay Z, Tortop T. Dentofacial effects of a modified tandem traction bow appliance. Eur J Orthod. 2010 Dec;32(6):655-61. doi: 10.1093/ejo/cjp153. Epub 2010 Mar 26.
PubMed 20348164Kapur A, Chawla HS, Utreja A, Goyal A. Early class III occlusal tendency in children and its selective management. J Indian Soc Pedod Prev Dent. 2008 Sep;26(3):107-13. doi: 10.4103/0970-4388.43191.
PubMed 18923222
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Modified Fixed Mandibular Retractor Appliance in the Treatment of Class III Malocclusion: A Clinical Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03354442
- Acronym / sponsor ID
- UDDS-Ortho-08-2017
- Conditions
- Malocclusion, Angle Class III
- Keywords
- Class III treatment, Modified Fixed Mandibular Retractor Appliance, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 28 Nov 2017 (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.
This experimental study aims to evaluate the efficiency of the Modified Fixed Mandibular Retractor Appliance in the treatment of skeletal class III malocclusion.
The study sample will consist of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly into two groups: experimental group and untreated control group.
The soft and hard tissue changes will be assessed using lateral cephalometric radiographs before the treatment and after obtaining 3mm positive overjet.
Detailed description
This research aimes to evaluate the effects of a Class III functional appliance [the modified fixed mandibular retractor (MFMR)] in the early treatment of skeletal Class III deformities.
It was not ethical to expose all candidate children to radiographic examination. Therefore, the assessment of skeletal Class III malocclusion was based on clinical judgment. Each patient was examined, while his/her mandible was kept at its retruded contact position to evaluate both jaws in space. Those who met the inclusion criteria were then sent to the radiographic department.
The radiographic lateral cephalograms were obtained in the patients' habitual occlusion.
All patients in the treatment group were treated by one specialist orthodontist 'AA' using the MFMR. The appliance consisted of the following elements: (1) Two acrylic upper posterior bite planes which cover the deciduous and permanent molars ( 2) Two transpalatal arch (0.8-mm TMA) with opposite U loop, the anterior one is near the first deciduous molars while the posterior one is near the first permanent molars (3) upper reversed labial bow (0.9-mm stainless steel) extending to the cervical edges of the mandibular anterior teeth from the labial surface of the lower primary canine on one side to the other labial surface of the contralateral tooth. This bow will be activated to hold the mandible in its maximum posterior physiologic position; and (4) the anterior spring (0.8-mm TMA) which starts from the acrylic bite plane in both sides, makes loop, then bends to touch the cingulum of upper incisors to procline the upper permanent incisors when diagnosed as retroclined.
The untreated group will receive no orthodontic treatment during the observation period. According to the Dental School Local Research Ethics Committee's guidelines, all children in the untreated group will receive orthodontic treatment after the end of the observational period of the study at no cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Fixed Mandibular Retractor | Experimental | Device: Modified Fixed Mandibular Retractor ApplianceAll patients in this group will be treated using Modified Fixed Mandibular Retractor Appliance. This appliance will be used full-time. |
| Untreated control group | No intervention | –All patients in this group will be observed during the period of treating the patients in the other group to assess the growth changes. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients in early mixed dentation (7-9 years old).
- Skeletal class III caused by mandibular prognathism with or without maxillary deficiency judged clinically and confirmed radiographically (ANB≤1).
- Anterior crossbite on two teeth or more.
- Normal inclination of the lower incisors with the mandibular plane.
- Good oral hygiene.
Key exclusion criteria (6 listed)
- Poor oral hygiene.
- Previous orthodontic treatment.
- Patients with syndromes, clefts, or craniofacial abnormalities.
- Severe skeletal class III resulting primarily from mandibular prognathism (ANB less than - 4 with no functional shift on closure)
- Patients with facial asymmetry.
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 |
|---|---|---|
| Modified Fixed Mandibular Retractor ApplianceAll patients with Class III malocclusion will be treated using the Modified Fixed Mandibular Retractor Appliance | Device | Modified Fixed Mandibular Retractor |
Primary outcome
ANB angle changes
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
5 secondary outcomes
SNA angle changes
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
SNB angle changes
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Profile changes
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Upper incisor angle changes
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Lower incisor angle changes
Time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Background: PubMed 17315814Alhaija ES. Skeletal, dental and soft tissue changes in postural class III malocclusion treated with a maxillary removable appliance. J Clin Pediatr Dent. 2006 Winter;31(2):149-52. doi: 10.17796/jcpd.31.2.u286433up81kt472.
- Background: PubMed 26446505Akin M, Ucar FI, Chousein C, Sari Z. Effects of chincup or facemask therapies on the orofacial airway and hyoid position in Class III subjects. J Orofac Orthop. 2015 Nov;76(6):520-30. doi: 10.1007/s00056-015-0315-3.
- Background: PubMed 27443361Majanni AM, Hajeer MY. The Removable Mandibular Retractor vs the Bone-anchored Intermaxillary Traction in the Correction of skeletal class III Malocclusion in children: A Randomized Controlled Trial. J Contemp Dent Pract. 2016 May 1;17(5):361-71. doi: 10.5005/jp-journals-10024-1856.
- Background: PubMed 21806467Seehra J, Fleming PS, Mandall N, Dibiase AT. A comparison of two different techniques for early correction of Class III malocclusion. Angle Orthod. 2012 Jan;82(1):96-101. doi: 10.2319/032011-197.1. Epub 2011 Aug 1.
- Background: PubMed 20348164Atalay Z, Tortop T. Dentofacial effects of a modified tandem traction bow appliance. Eur J Orthod. 2010 Dec;32(6):655-61. doi: 10.1093/ejo/cjp153. Epub 2010 Mar 26.
- Background: PubMed 18923222Kapur A, Chawla HS, Utreja A, Goyal A. Early class III occlusal tendency in children and its selective management. J Indian Soc Pedod Prev Dent. 2008 Sep;26(3):107-13. doi: 10.4103/0970-4388.43191.
- Individual participant dataSharing planned: No. The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
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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.
Ahmad S Burhan, PhD. study chair
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Fixed Mandibular Retractor Appliance in people with Malocclusion, Angle Class III, run by Damascus University at 1 site in Syria.
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 5 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: finished, as of the sponsor's last update on 18 Jul 2019. 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANB angle changes (time frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months). 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 NCT03354442, which also lists 6 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 18 Jul 2019.