Assessment of Dentoskeletal Changes After Treatment of Skeletal classII by Twinblock Versus Monoblock Appliances
1 other identifier
interventional
18
1 country
1
Brief Summary
Assessment of dentoskeletal changes after treatment of skeletal classII growing patient by twin block versus mono block ,clinical trial stuy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
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
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2025
CompletedFirst Submitted
Initial submission to the registry
November 16, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedDecember 11, 2025
November 1, 2025
1.8 years
November 16, 2025
November 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
skeletal classII correction and dental changes
standerized extraoral radiograph and Cone-Beam Computed Tomography(CBCT)
8_12 month
Secondary Outcomes (1)
Assessment of airway changes
8-12month
Study Arms (2)
treatment of skeletal classII by twin block
EXPERIMENTALgrowing patient wearing twin block appliance15 hrs/day
treatment of skeletal classII by monoblock
EXPERIMENTALgrowing patients wearing monoblck appliance15hrs/day
Interventions
bite registration at edge to edge position ,mono block wearing 15hrs/day
bite registration at edge to edge position ,twin block wearing 15hrs/day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shimaa Nasr
Cairo, Egypt
Related Publications (1)
Sakuno AC, da Rosa APB, Maeda FA, Trivino T, Carvalho PEG, Torres FC. Tomographic evaluation of dentoskeletal changes due to the treatment of class II malocclusion with Forsus appliance. J Oral Biol Craniofac Res. 2019 Jul-Sep;9(3):277-279. doi: 10.1016/j.jobcr.2019.06.005. Epub 2019 Jun 5.
PMID: 31289716RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Maha Mostafa Mohammed, Ass.Professor
Ass.Professor of Orthodontics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
November 16, 2025
First Posted
December 11, 2025
Study Start
October 25, 2023
Primary Completion
August 25, 2025
Study Completion
September 25, 2025
Last Updated
December 11, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share