NCT07117006

Brief Summary

Here's a 1,000-word (quarter-length) concise version of your research brief, preserving the key structure and essential details: Brief Summary: Comparative Management of Skeletal Anterior Open Bite Using Mini-Screw Supported Intrusion with Clear Aligners Versus Fixed Appliances PICO elements Population: Adults (17-25 years) with uncompensated skeletal anterior open bite. Intervention: TAD-supported intrusion with clear aligners. Comparison: TAD-supported intrusion with fixed appliances. Outcomes: Primary: Anterior open bite closure. Secondary: Molar intrusion, mandibular autorotation, incisor movement and quality of life.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 5, 2025

Last Update Submit

August 5, 2025

Conditions

Skeletal Open BiteOpen BiteMaxillary IntrusionMini-screwsClear Aligner Appliance

Keywords

OpenbiteSkeletal anchorageFixed applianceAlignersIntrusion

Outcome Measures

Primary Outcomes (1)

  • Anterior open bite closure

    the anterior open bite will be measured between the incisors using a digital caliper

    6 months

Secondary Outcomes (2)

  • amount of maxillary posterior teeth intrusion

    6 months

  • Amount of mandibular posterior teeth extrusion

    6 months

Study Arms (1)

comparator- fixed appliance

ACTIVE COMPARATOR

miniscrew-supported maxillary posterior segments' intrusion will be done using fixed appliances

Device: miniscrew- supported maxillary posterior segments' intrusion using clear aligners

Interventions

miniscrew- supported maxillary posterior segments' intrusion using clear alignersDEVICE

maxillary posterior segments will be intruded with the aid of miniscrews and clear aligners

comparator- fixed appliance

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • uncompensated skeletal openbite with normal incisal show at rest and smiling
  • good oral hygeine

You may not qualify if:

  • systemic disease
  • extraction or missing dentition
  • root resorption in posterior teeth
  • carious or fractured upper posterior teeth peridontal affected upper posterior teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, cairo university

Cairo, Cairo Governorate, 11528, Egypt

Location

MeSH Terms

Conditions

Open Bite

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
statistician will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at International Orthodontic Program (IOP)

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

December 30, 2024

Primary Completion

December 30, 2025

Study Completion

February 1, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)