CompletedNot Applicable

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

Syria30 participantsStarted 2023-06-15

Plain-language 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 selection criteria are accurately matched. 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).

Who can participate

Age range

9 Years – 13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the SNA angle

Timeframe: 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

Change in the ANB angle

Change in the S.N.Pog angle

Change in the SN-MaxP angle

Trial details

NCT IDNCT06596239

SponsorDamascus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-15

View on ClinicalTrials.gov More Class III Malocclusion trials