CompletedNot Applicable

The Efficacy of Tow Mechanics for Total-maxillary-arch-distalization

Syria48 participantsStarted 2022-05-20

Plain-language summary

Patients with class II division 1 malocclusion who have increased overjet will be treated in this study. The efficacy of one-jaw and tow-jaw mechanics for mini-implants anchored total-maxillary-arch-distalization in the treatment of class II division 1 malocclusion will be assessed. The skeletal, dental and soft tissues changes resulted by these tow interventions will be studied. As well as, the pain levels, oral-health related quality of life during all stages of the treatment and the smile components will be explored and compared with the traditional treatment results of this type of malocclusion (en-mass retraction with first premolars extraction). There are three groups : 1. a group of patients in which participants will be undergo to the one-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (mini-implants in the maxillary arch). 2. a group of patients in which participants will be undergo to the tow-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (mini-implants in the mandibular arch with class II elastics). 3. a group of patients in which participants will be undergo to the en-mass retraction with first premolars extraction with mini-implants in the maxillary arch.

Who can participate

Age range

17 Years – 30 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: * Adult patients with permanent occlusion at age 18-30 years. * Comprehensive medical and dental history ruling out any systemic disease * Not under any systemic medication. * No previous orthodontic treatment * Patients with satisfactory periodontal health and Good oral hygiene * Need to orthodontic treatment with fixed appliances * No congenitally missing teeth except third molars in the maxillary arch * Mild or no anterior crowding in maxillary arch. * Patients with class Ⅱ division 1 (ANB angle ≤7 degrees) with severe overjet (5-9 mm) * Maximum retraction of the anterior teeth was desired. Exclusion Criteria: * Patients with previous orthodontic treatment. * Patients with severe skeletal dysplasia in all three dimensions. * Patients suffer from systemic diseases or syndromes * Patients on medication for systemic disorders, pregnancy or steroid therapy. * Patients showing any signs of active periodontal disease * Patients with severe crowding (≥ 3.5 mm) in maxillary arch * Patients with missing or extracted teeth in maxillary arch except third molar.

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

Duration of the treatment

Timeframe: duration (in months) between T0: the beginning of active treatment, T1: when a normal overjet and canines class I relationships achieved. (expected to be within 6 months in the exp. groups and 8 months in the control group)

Change in the Incisors' positions

Timeframe: : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group

Change in Molars' positions

Change in the SNA angle

Change in the SNB angle

Trial details

NCT IDNCT04814173

SponsorHama University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

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