Assessment of Dentoskeletal Changes After Treatment of Skeletal classII by Twinblock Versus Monoblock Appliances

November 29, 2025 updated by: Shimaa Nasr, Faculty of Dental Medicine for Girls

Assessment of Dentoskeletal Changes After Treatment of Skeletal classII Growing Patient by Twinblock Versus Monoblock Appliance

Assessment of dentoskeletal changes after treatment of skeletal classII growing patient by twin block versus mono block ,clinical trial stuy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Group(A):patients will be treated with twinbLock Group(B):patients will be treated with monobLock

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Shimaa Nasr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients to avoid any sexual dimorphism which may affect the comparison.
  • Skeletal Class II (ANB° > 5°) with normal maxilla (SNA° = 82° ±4°) and retrognathic mandible (SNB° < 87°).
  • Age range from 9 to 12 years.

Exclusion Criteria:

  • Previous history of orthodontic treatment.
  • Congenitally missing or extracted permanent teeth.
  • Posterior cross bites or severe maxillary transverse deficiency.
  • Severe facial asymmetry determined by clinical or radiographic examination.
  • Poor oral hygiene.
  • Systemic diseases that may affect the treatment results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment of skeletal classII by twin block
growing patient wearing twin block appliance15 hrs/day
Device: wearing of twinblock after bite correction
bite registration at edge to edge position ,twin block wearing 15hrs/day
Experimental: treatment of skeletal classII by monoblock
growing patients wearing monoblck appliance15hrs/day
Device: wearing of monoblock after bite correction
bite registration at edge to edge position ,mono block wearing 15hrs/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skeletal classII correction and dental changes
Time Frame: 8_12 month
standerized extraoral radiograph and Cone-Beam Computed Tomography(CBCT)
8_12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of airway changes
Time Frame: 8-12month
cone beam computed tomography(cbct)
8-12month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Principal Investigator: Maha Mostafa Mohammed, Ass.Professor, Ass.Professor of Orthodontics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Actual)

August 25, 2025

Study Completion (Actual)

September 25, 2025

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 29, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ORTHO-108-2-H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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