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Skeletal and Dentoalveolar Effects of Functional Clear Aligner Therapy in Growing Patient With Skeletal Class III Malocclusion

NCT07703007 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-07-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the skeletal, dentoalveolar \& soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. Skeletal class III discrepancy has been a therapeutic challenge due to the fact that its therapeutic management seeks not only the correction of the malocclusion but also the aesthetic component of the patient which is affected according to the severity of the discrepancy. 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. Removable aesthetic appliance therapy as clear aligner becomes an increasingly common addition to the orthodontic armamentarium. It offers certain advantages over traditional appliance orthodontic treatments; these include fewer clinical emergencies and improved aesthetics, comfort, oral hygiene, periodontal health, and lack of soft tissue irritation. The aim of this study is to evaluate the skeletal, dentoalveolar \& soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. A total of four blocks are digitally designed, with two blocks placed in the maxillary aligner in the anterior region and two blocks placed in the mandibular aligner in the posterior region. The blocks are designed as inclined planes to guide mandibular repositioning, simulating the reverse twin block mechanism. The upper and lower bite blocks are designed to interact with each other through coherent, specifically designed 70° inclined planes, allowing controlled mandibular repositioning during occlusal contact. Optimized attachments are digitally placed on selected teeth to enhance aligner retention and control tooth movement. 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

Functional Clear Aligner

A customized functional clear aligner appliance designed as a reverse twin block for growing patients with skeletal Class III malocclusion. The appliance incorporates digitally designed anterior maxillary and posterior mandibular bite blocks with 70° inclined planes to guide controlled mandibular repositioning while maintaining the esthetic and functional advantages of clear aligner therapy.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-02-12
Primary Completion
2027-02-13
Completion
2027-07-13

Countries

  • Egypt

Study Locations

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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 NCT07703007 on ClinicalTrials.gov