MedTrace Logo

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

NCT07376954 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-01-29

No results posted yet for this 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.

Conditions

  • Skeletal Class III Malocclusion

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2026-05-20
Completion
2026-10-20

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07376954 on ClinicalTrials.gov