By InvitationPhase 1

Management of Skeletal Class III Malocclusion With Digital Bonded Reverse Twin Block in Mixed Dentition

Egypt21 participantsStarted 2025-05-19

Plain-language summary

The purpose of this study is to evaluate dentoalveolar \& skeletal effects of digital bonded reverse twin block in treatment of skeletal class III malocclusion in mixed dentition. Class III malocclusion presents significant management and prognostic challenges due to the complex interplay of factors in its etiology. Early diagnosis, planning of adequate therapeutic time and choice of devices to correct malocclusion are the essential keys to successful management of class III in all its forms. Functional appliances are commonly used for the treatment of skeletal class III malocclusion. The aim of this study is to evaluate dentoalveolar \& skeletal effects of digital bonded reverse twin block (DBRTB) in treatment of skeletal class III malocclusion in mixed dentition. The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention. The DBRTB will be designed as four occlusal blocks, two blocks for the upper arch, and two blocks for the lower arch. The upper blocks will be bonded to the anterior part of the maxillary arch, the lower blocks will be bonded to the posterior part of the mandibular arch. Upper and lower blocks will interact with each other through coherent specifically designed 70° inclined planes. Transfer transparent trays will be used to support the bonding procedure of the blocks. Oral Health Related Quality of Life (OHRQoL) assessments will be incorporated as an outcome measure in addressing and measuring clinically meaningful change.

Who can participate

Age range

8 Years – 11 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: * Patients' age (8-11) years (CVM stages 2-3) * Mild class III skeletal pattern (Wits appraisal = 0 to -8) * Mixed dentition * Mild to moderate reverse overjet (-1 to -4) * Overbite (1-5) * Average or below average maxillary mandibular plane angle and lower facial height * Mild incisors compensations Exclusion Criteria: * Severe class III skeletal pattern * Long facial height * Bad oral hygiene * Systemic condition that may interfere with treatment * No premolars or deciduous molars

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

Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition

Timeframe: 12 months

Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition

Timeframe: 12 months

Trial details

NCT IDNCT07376954

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-20

View on ClinicalTrials.gov More Skeletal Class III Malocclusion trials