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Clinical Trials in Egypt / NCT07376954
Enrolling by invitation Phase 1

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

NCT07376954 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 1
Started
2025-05-19
Last updated
2026-01-29

Condition(s) studied

Skeletal Class III Malocclusion

Investigational drug(s) / intervention(s)

Digital Bonded Reverse Twin Block

Digital Bonded Reverse Twin Block: Appliance construction: * upper blocks (right and left) to be bonded on the anterior region of the maxillary arch. * lower blocks (right and left) to be bonded on the posterior region of the mandibular arch. Both upper and lower blocks will be produced using Poly-Methyl-Meth-Acrylate (PMMA). Upper and lower blocks will interact with each other through coherent specifically designed 70° inclined planes. Transparent Polyethylene 0.8mm trays will be used to assist the clinician during the blocks bonding procedures.

Study 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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
11 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Mansoura University Al Mansurah Egypt

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07376954 on ClinicalTrials.gov ↗ ← All trials in Egypt