RecruitingACTRN12622000310763

Evaluation of two types of treatment for adolescent patients with protrusion of lower jaw and constriction of upper jaw

Evaluation of the effectiveness of the Removable Mandibular Retractor with Slow Maxillary Expansion compared to the Bone-anchored Intermaxillary Traction with Rapid Maxillary Expansion in the Correction of Skeletal class III malocclusion associated with maxillary constriction in growing patients between 12 - 15 years.: A Randomized Controlled Trial


Sponsor

Universiti Sains Malaysia

Enrollment

42 participants

Start Date

Jul 1, 2023

Study Type

Interventional

Conditions

Summary

Study of the anterior bone defect located in the upper and lower jaws and correct this defect using two devices and compare them in patients aged 12 to 15 years


Eligibility

Sex: Both males and femalesMin Age: 12 YearssMax Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

Some children have a dental condition where the lower jaw protrudes further forward than the upper jaw, combined with a narrow upper jaw — this is called a Class III malocclusion. It can affect chewing, speaking, and confidence. Treating this while children are still growing gives the best chance of good results without the need for later surgery. This Malaysian study compares two orthodontic devices used to correct this alignment problem in children aged 12–15. Both devices work by helping the upper jaw grow forward and widen, but they use different mechanisms. Researchers will measure changes to the jaw bones and teeth using X-rays and clinical assessments to see which device is more effective. You may be eligible if you are a Malaysian patient aged 12–15, have permanent adult teeth, have been diagnosed with a Class III jaw relationship with specific bone measurements, and have not had previous orthodontic treatment. Children with craniofacial syndromes, cleft palate, missing teeth, or asymmetric jaws are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

For the BAIMT with RME group: The duration of the procedure will be about 12 months included Sagittal and transverse correction stage and retention stage . This procedure will be carried out ini

For the BAIMT with RME group: The duration of the procedure will be about 12 months included Sagittal and transverse correction stage and retention stage . This procedure will be carried out initially by the orthodontist and later by The patient or one of his parents The patient or one of his parents will activate the expander twice daily (0.4 mm) until an overcorrection of maxillary constriction about 2-3 mm will be obtained (experimental group): bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion(RME) group Orthodontic procedures: 1. Active phase period: The group: BAIMT with RME The appliance consists of (1) bonded modified Hyrax palatal expander with occlusal splints bonded with GIC on the upper premolars/deciduous molars and upper first molars, (2) hooks (made of 0.9 mm stainless steel wire) for attaching elastic bands placed distal to the first molars . Two self-drilling mini-implants (1.6 mm diameter, 8 mm length) will be inserted under local anesthesia into the buccal alveolar bone between the mandibular canine and the first premolar roots on both sides with an insertion angle of about 45° to 60° with the alveolar process. A periapical radiograph will be taken beforehand to assure proper insertion without damaging the neighboring roots . Intermaxillary elastics will be applied between the hooks and the mandibular anterior mini-implants, generating a 100 g force on each side of the jaw; in the first week (5/16 inch) followed by 3/16 medium size to generate an orthodontic force of about 200 g on each side until the end of treatment. Patients will be asked to wear elastics for 16 hours per day and replace elastics daily or when they will get damaged . The patient or one of his parents will activate the expander twice daily (0.4 mm) until an overcorrection of maxillary constriction about 2-3 mm will be obtained . The patients in the two groups will be seen within one week, following the appliance’s first insertion, two weeks following the first insertion, and then at monthly visits to observe the change in incisor relationship, monitor patient’s compliance by the researcher himself . Change in the incisor relationship from a negative overjet (i.e., + 1.5 mm or greater) will be considered the sign of successful treatment in the sagittal plane. If the defect in the transverse plane will be corrected before the one in the sagittal plane, the expansion will be stopped while the patient will be asked to continue wearing the appliance until the defect in the sagittal plane will be corrected and vice versa. The questionnaire will be distributed to the patients at five times by the researcher himself: (T1) after one day of the beginning of the treatment, (T2) after one week (T3) after four weeks, (T4) after three months, (T5) after six months. The questionnaire will be filled in by the patient at the five times.


Locations(2)

Syrian Arab Republic

Syrian Arab Republic

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ACTRN12622000310763