Evaluation of Pain and Functional Impairments When Treating Class III Malocclusion Using Two Trea… (NCT06877780) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Pain and Functional Impairments When Treating Class III Malocclusion Using Two Treatment Procedures
Syria24 participantsStarted 2021-09-01
Plain-language summary
A clinical examination of each recalled candidate patient will be carried out at Adib Al Lahham Centre at the Ministry of Health Damascus to ensure that he/she meets the inclusion criteria. Following obtaining the full records, including a lateral cephalometric radiograph, additional checking will be made to classify the skeletal relationship (class III relationship) of each possible candidate for this work.
This trial compares two groups of patients who suffered from Class III malocclusion associated with maxillary constriction.
Experimental Group: Patients in this group will undergo treatment using bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion (RME).
Control Group: Patients in this group will undergo treatment using a removable mandibular retractor (RMR) associated with slow maxillary expansion (SME).
Who can participate
Age range
12 Years – 15 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:
* Growing patients between the ages of 12-15 of either gender.
* Angle's class III malocclusion.
* Skeletal class III (-4 \< ANB \< + 1).
* Anterior crossbite involving two or more teeth or edge-to-edge incisor relationship with or without a forward shift of the mandible during closure.
* The incisor mandibular plane's (IMPA) angle should be between 85° and 100°.
* Maxillary constriction necessitates expansion.
Exclusion Criteria:
* Skeletal class III malocclusion is mainly caused by maxillary retrognathism.
* Severe skeletal class III, mainly resulting from mandibular prognathism.
* Contraindications for the application of the mini-screws.
* The presence of supernumerary teeth or missing ones except for the third molars.
* The presence of cleft lip or craniofacial syndromes and/or palate abnormalities.
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
1
Change in the feeling of pressure at the soft tissues
Timeframe: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
2
Change in the perception of pain
Timeframe: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.