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

NCT07376954 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: Eman Abdelkhabir
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Skeletal class III malocclusion; Digital bonded reverse twin block; Mixed dentition

Outcome Measures

Primary Outcomes (2)

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

  Digital Bonded Reverse Twin Block is composed of four fixed blocks , 2 blocks cemented on upper premolars or deciduous molars \& 2 blocks cemented on lower permanent molars with inclined planes 70 degrees One of the most engaging aspects of the DBRTB is its immediate facial treatment effects. Patient and their parents, immediately had the perception of facial profile modification. These facial changes can significantly improve the psychological patient's condition, improving their self-esteem and potentially making patients more confident. 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 dental effect of DBRTB is proclination of upper incisors, retroclination of lower incisors The skeletal effect of DBRTB is evaluated from cephalometric measurements: increase in SNA, decrease in SNB and ANB after ttt of mild skeletal class III cases

  12 months

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

  Digital Bonded Reverse Twin Block is composed of four fixed blocks , 2 blocks cemented on upper premolars or deciduous molars \& 2 blocks cemented on lower permanent molars with inclined planes 70 degrees. One of the most engaging aspects of the DBRTB is its immediate facial treatment effects. Patient and their parents, immediately had the perception of facial profile modification. These facial changes can significantly improve the psychological patient's condition, improving their self-esteem and potentially making patients more confident. 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 dental effect of DBRTB is proclination of upper incisors, retroclination of lower incisors The skeletal effect of DBRTB is evaluated from cephalometric measurements: increase in SNA, decrease in SNB and ANB after ttt of mild skeletal class III cases

  12 months

Secondary Outcomes (1)

• OHRQoL (Oral Health-related Quality of Life) assessments are being incorporated into clinical studies and trials to measure efficaciousness of treatment with the goal of improving care.

  12 months

Study Arms (2)

Growing patients with mild skeletal class III

ACTIVE COMPARATOR

Digital Bonded Reverse Twin Block

Device: Digital Bonded Reverse Twin Block

Retrospective skeletal class III patients

NO INTERVENTION

Untreated

Interventions

Digital Bonded Reverse Twin Block DEVICE

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.

Growing patients with mild skeletal class III

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe class III skeletal pattern
• Long facial height
• Bad oral hygiene
• Systemic condition that may interfere with treatment
• No premolars or deciduous molars

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Digital Bonded Reverse Twin Block

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 29, 2026
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-05

Locations

EG (1)