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

NCT07703007 | Enrolling By Invitation DMC

• 1 other identifier: Eman Elsayed Ali Hashish
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

skeletal class III malocclusion; Functional clear aligner; Growing patient; Growth modification

Outcome Measures

Primary Outcomes (3)

• Change in skeletal cephalometric measurements

  Anteroposterior and vertical skeletal changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include SNA (°), SNB (°), ANB (°), Wits appraisal (mm), lower anterior facial height (LAFH, mm), upper anterior facial height (UAFH, mm), total anterior facial height (TAFH, mm), posterior facial height (PFH, mm), Frankfort mandibular plane angle (FMA, °), and Y-axis angle (°).

  Baseline and at the end of active treatment.

• Change in dentoalveolar cephalometric measurements

  Dentoalveolar changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include upper incisor inclination to the SN plane (U1-SN, °), lower incisor inclination to the mandibular plane (IMPA, °), interincisal angle (°), U1-NA (mm and °), and L1-NB (mm and °)

  Baseline and at the end of active treatment.

• Change in soft tissue cephalometric measurements

  soft tissue changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include upper lip to E-line (UL-E, mm), lower lip to E-line (LL-E, mm), and nasolabial angle (°).

  Baseline and at the end of active treatment.

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 (1)

Growing patients with mild skeletal class III

EXPERIMENTAL

Functional Clear Aligner

Device: Functional Clear Aligner

Interventions

Functional Clear Aligner DEVICE

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.

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)
• Mild to moderate reverse overjet (-1 to -4)
• Overbite (1-5)
• Growing patients
• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Functional Clear Aligner

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 14, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): February 13, 2027
• Study Completion (Estimated): July 13, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)