Class III MalocclusionNCT06596239

Evaluating the Effectiveness of the Lower-Clear-Plate-Based Intermaxillary Traction

A study testing lower-clear-plate-based intermaxillary traction (LCP-IMT) and Removable mandibular retractor (RMR) in people with Class III Malocclusion, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure the… Read more about this study

Who is it for?: Ages 9 to 13 years
Conditions the study is for: Class III Malocclusion
What is being tested?: lower-clear-plate-based intermaxillary traction (LCP-IMT) and Removable mandibular retractor (RMR)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSyria
Study dates: 15 Jun 2023to 15 Jun 2024
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 9 to 13 years
All sexes
No healthy volunteers
Child

Who may be able to join

Class III dental malocclusion at the molar relationship, according to Angle's classification
Presence of an anterior crossbite on two or more teeth or an edge-to-edge relationship at the anterior teeth
Mild to moderate skeletal Class III in the late mixed occlusion stage (9-13 years old) or the beginning of permanent occlusion (not exceeding 13 years old; ANB = +1 to -4 degrees)
Normal or horizontal growth pattern (MM ≤ 35; SN.ManP ≤ 40)
Normal or labial inclination of the lower incisors (IMPA = 85 to 100 degrees)
Patient's willingness to cooperate during the orthodontic treatment period

Who cannot join

Class III skeletal relationship caused solely by the maxillary recession (SNA < 78 and a normal SNB angle)
An indication of RME
Presence of clear asymmetry (deviation of mandibular midline more than 2 mm from facial midline)
Presence of any craniofacial syndromes (such as cleft lip or palate)
Systemic diseases; previous facial trauma; and Previous orthodontic treatment.

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Damascus, DM20 HAJ72

Other trials in Syria

About this study

Official title: Hard- and Soft-tissue Changes Following Class III Treatment With the Lower-Clear-Plate-Based Intermaxillary Traction Versus the Removable Mandibular Retractor: a Two-arm Randomized Controlled Clinical Trial

This study compares two groups of patients with mild to moderate skeletal Class III in the late mixed occlusion stage. Experimental group: the patients in this group will be treated with Lower-Clear-Plate Based Intermaxillary Traction Control group: the patients in this group will be treated using the Removable Mandibular Retractor (RMR).

Read the detailed description

There are different methods of correcting Class III deformity in Orthodontics. Lower-clear-plate-based intermaxillary traction has been shown to be an effective method of managing these cases. This treatment modality has not been compared with the well-known appliance (the removable mandibular retractor; RMR). Therefore, the current study compares both groups of growing children with Class III malocclusion. The study design is a randomized controlled trial.

Conditions: Class III Malocclusion
Being tested: lower-clear-plate-based intermaxillary traction (LCP-IMT), Removable mandibular retractor (RMR)
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.

lower-clear-plate-based intermaxillary traction (LCP-IMT)Device
The patient is instructed to apply elastics between the upper molar bands and the hooks on the lower clear plates.
Removable mandibular retractor (RMR)Device
An appliance is worn on the upper jaw, which affects the lower jaw by using an inferiorly extended labial bow.

Study groups in NCT06596239
Study group	Role	What they receive
Lower-clear-plate-based intermaxillary traction (LCP-IMT)	Experimental	Patients in this group will be treated using the LCP-IMT technique. Receives: Device: lower-clear-plate-based intermaxillary traction (LCP-IMT)
Removable mandibular retractor (RMR)	Active comparator	Patients in this group will be treated using the RMR appliance. Receives: Device: Removable mandibular retractor (RMR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the SNA angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the SNB angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the ANB angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the S.N.Pog angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the chin in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the SN-MaxP angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper jaw plane and the cranial base in the vertical direction of cephalometric analysis.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the SN-ManP angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower jaw plane and the cranial base in the vertical direction of cephalometric analysis.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the MaxP.ManP angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Wits appraisal
Lateral cephalometric images were taken for each patient. This was measured millimetres horizontally from the projection of points A (AO) and B (BO) along the functional occlusal plane.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the U1.SN angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper central incisor axis and the cranial base in the anteroposterior direction of cephalometric analysis.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the L1-GoMe angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower central incisor axis and the mandibular plane in the anteroposterior direction of cephalometric analysis.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the overbite (Ovb)
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the overjet (Ovj)
Lateral cephalometric images were taken for each patient. This was measured millimetres Horizontally from the upper to the lower central incisors.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group

Secondary outcomes (5)

Change in the Soft tissue convexity angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle is to evaluate the profile of the face. It is formed by the intersection of two lines: one from the glabella (the area between the eyebrows) to the subnasale (the point where the nose meets the upper lip), and another from the subnasale to the pogonion (the most forward point on the chin in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Ls-Esth measurement
Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale superius and E-Line of Ricketts.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Li-Esth measurement
Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale inferius and E-Line of Ricketts.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Nasolabial angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the nose and the upper lip in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Mento-labial angle
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the chin and the lower lip in the cephalometric analysis in the anteroposterior direction.
Measured: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202315 Jun 2024

First posted19 Sep 2024
Study start15 Jun 2023
Primary completion15 Mar 2024
Study completion15 Jun 2024

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 Class III MalocclusionStudies 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06596239
Sponsor's protocol ID: UDDS-Ortho-4-2024
Status last verified: Sep 2024
First submitted: 11 Sep 2024
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Husson AH, Burhan AS, Hajeer MY, Nawaya FR. Evaluation of the dimensional changes in the mandible, condyles, and the temporomandibular joint following skeletal class III treatment with chin cup and bonded maxillary bite block using low-dose computed tomography: A single-center, randomized controlled trial. F1000Res. 2023 Mar 13;12:264. doi: 10.12688/f1000research.130941.1. eCollection 2023.
PubMed 37008891
Garattini G, Levrini L, Crozzoli P, Levrini A. Skeletal and dental modifications produced by the Bionator III appliance. Am J Orthod Dentofacial Orthop. 1998 Jul;114(1):40-4. doi: 10.1016/s0889-5406(98)70235-5.
PubMed 9674678
Saleh M, Hajeer MY, Al-Jundi A. Short-term soft- and hard-tissue changes following Class III treatment using a removable mandibular retractor: a randomized controlled trial. Orthod Craniofac Res. 2013 May;16(2):75-86. doi: 10.1111/ocr.12007. Epub 2012 Nov 8.
PubMed 23323964
Majanni 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 27443361
Baccetti T, Tollaro I. A retrospective comparison of functional appliance treatment of Class III malocclusions in the deciduous and mixed dentitions. Eur J Orthod. 1998 Jun;20(3):309-17. doi: 10.1093/ejo/20.3.309.
PubMed 9699409
Kheshfeh MN, Nassar N, Hajeer MY, Aljabban O, Alam MK. Hard- and soft-tissue changes following the treatment of growing patients with skeletal class III malocclusion using the lower-clear-plate based intermaxillary traction versus the removable mandibular retractor: a two-arm randomized controlled trial. BMC Oral Health. 2025 Dec 5;26(1):61. doi: 10.1186/s12903-025-07474-1.
PubMed 41350990

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Maxillary Retrognathism, Children
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Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
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Malocclusion, Angle Class I, Malocclusion, Angle Class II
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion

All Class III Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hard- and Soft-tissue Changes Following Class III Treatment With the Lower-Clear-Plate-Based Intermaxillary Traction Versus the Removable Mandibular Retractor: a Two-arm Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT06596239
Acronym / sponsor ID: UDDS-Ortho-4-2024
Conditions: Class III Malocclusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 15 Jun 2023 (actual)
Primary completion: 15 Mar 2024 (actual)
Study completion: 15 Jun 2024 (actual)
First posted: 19 Sep 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lower-clear-plate-based intermaxillary traction (LCP-IMT)	Experimental	Device: lower-clear-plate-based intermaxillary traction (LCP-IMT)Patients in this group will be treated using the LCP-IMT technique.
Removable mandibular retractor (RMR)	Active comparator	Device: Removable mandibular retractor (RMR)Patients in this group will be treated using the RMR appliance.

Who may qualify

Ages: 9 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Class III dental malocclusion at the molar relationship, according to Angle's classification
Presence of an anterior crossbite on two or more teeth or an edge-to-edge relationship at the anterior teeth
Mild to moderate skeletal Class III in the late mixed occlusion stage (9-13 years old) or the beginning of permanent occlusion (not exceeding 13 years old; ANB = +1 to -4 degrees)
Normal or horizontal growth pattern (MM ≤ 35; SN.ManP ≤ 40)
Normal or labial inclination of the lower incisors (IMPA = 85 to 100 degrees)

Key exclusion criteria (5 listed)

Class III skeletal relationship caused solely by the maxillary recession (SNA < 78 and a normal SNB angle)
An indication of RME
Presence of clear asymmetry (deviation of mandibular midline more than 2 mm from facial midline)
Presence of any craniofacial syndromes (such as cleft lip or palate)
Systemic diseases; previous facial trauma; and Previous orthodontic treatment.

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
lower-clear-plate-based intermaxillary traction (LCP-IMT)The patient is instructed to apply elastics between the upper molar bands and the hooks on the lower clear plates.	Device	Lower-clear-plate-based intermaxillary traction (LCP-IMT)
Removable mandibular retractor (RMR)An appliance is worn on the upper jaw, which affects the lower jaw by using an inferiorly extended labial bow.	Device	Removable mandibular retractor (RMR)

Primary outcome

Change in the SNA angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction.
Change in the SNB angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction.
Change in the ANB angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction.
Change in the S.N.Pog angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the chin in the cephalometric analysis in the anteroposterior direction.
Change in the SN-MaxP angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper jaw plane and the cranial base in the vertical direction of cephalometric analysis.
Change in the SN-ManP angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower jaw plane and the cranial base in the vertical direction of cephalometric analysis.
Change in the MaxP.ManP angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis.
Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees.
Change in the Wits appraisal
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient. This was measured millimetres horizontally from the projection of points A (AO) and B (BO) along the functional occlusal plane.
Change in the U1.SN angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper central incisor axis and the cranial base in the anteroposterior direction of cephalometric analysis.
Change in the L1-GoMe angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower central incisor axis and the mandibular plane in the anteroposterior direction of cephalometric analysis.
Change in the overbite (Ovb)
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.
Change in the overjet (Ovj)
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Lateral cephalometric images were taken for each patient. This was measured millimetres Horizontally from the upper to the lower central incisors.

5 secondary outcomes

Change in the Soft tissue convexity angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Ls-Esth measurement
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Li-Esth measurement
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Nasolabial angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group
Change in the Mento-labial angle
Time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group

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 19 Sep 2024.
Background: PubMed 37008891Husson AH, Burhan AS, Hajeer MY, Nawaya FR. Evaluation of the dimensional changes in the mandible, condyles, and the temporomandibular joint following skeletal class III treatment with chin cup and bonded maxillary bite block using low-dose computed tomography: A single-center, randomized controlled trial. F1000Res. 2023 Mar 13;12:264. doi: 10.12688/f1000research.130941.1. eCollection 2023.
Background: PubMed 9674678Garattini G, Levrini L, Crozzoli P, Levrini A. Skeletal and dental modifications produced by the Bionator III appliance. Am J Orthod Dentofacial Orthop. 1998 Jul;114(1):40-4. doi: 10.1016/s0889-5406(98)70235-5.
Background: PubMed 23323964Saleh M, Hajeer MY, Al-Jundi A. Short-term soft- and hard-tissue changes following Class III treatment using a removable mandibular retractor: a randomized controlled trial. Orthod Craniofac Res. 2013 May;16(2):75-86. doi: 10.1111/ocr.12007. Epub 2012 Nov 8.
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 9699409Baccetti T, Tollaro I. A retrospective comparison of functional appliance treatment of Class III malocclusions in the deciduous and mixed dentitions. Eur J Orthod. 1998 Jun;20(3):309-17. doi: 10.1093/ejo/20.3.309.
Derived from this study: PubMed 41350990Kheshfeh MN, Nassar N, Hajeer MY, Aljabban O, Alam MK. Hard- and soft-tissue changes following the treatment of growing patients with skeletal class III malocclusion using the lower-clear-plate based intermaxillary traction versus the removable mandibular retractor: a two-arm randomized controlled trial. BMC Oral Health. 2025 Dec 5;26(1):61. doi: 10.1186/s12903-025-07474-1.
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.

Mohammad Younis Hajeer study chair

Yes

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 5 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 19 Sep 2024. 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?

Change in the SNA angle (time frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group). The study lists 13 primary outcomes in all. 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 NCT06596239, 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 19 Sep 2024.