NCT05993156

Brief Summary

Effects of modified fixed twin block versus removable twin block on skeletal class 2 growing patients with mandibular deficiency: A Randomized Clinical Trial

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

July 6, 2023

Last Update Submit

August 13, 2023

Conditions

MalocclusionAngle Class IIMandible Small

Keywords

orthodonticsorthopedicsmyofunctional applianceTwinblock

Outcome Measures

Primary Outcomes (1)

  • Over jet reduction

    the horizontal distance between upper and lower incisors

    9 months

Secondary Outcomes (2)

  • Effective mandibular length

    9 months

  • lower incisor inclination

    9 months

Study Arms (2)

Removable twin block group

ACTIVE COMPARATOR

participants would receive conventional removable twin block for correction of class II malocclusion for 9 months

Device: removable twin block

Fixed twin block group

EXPERIMENTAL

participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months

Device: modified Fixed twinblock

Interventions

modified Fixed twinblockDEVICE

modified fixed twin block functional appliance, with cemented bands on the first molars

Also known as: F.T.B.
Fixed twin block group
removable twin blockDEVICE

Conventional Removable Clark twin block myofunctional appliance

Also known as: R.T.B.
Removable twin block group

Eligibility Criteria

Age9 Years - 15 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Skeletal Class 2 malocclusion cases (ANB ≥ 5 degrees)
  • Overjet ≥ 5 mm
  • Growing patients (CVMS 3 or 4)

You may not qualify if:

  • Skeletally mature patients 15 years old or above
  • Patients with normal mandible and only protruded upper incisors.
  • Syndromic, cleft patients and patients with dental anomalies
  • Previous orthopaedic or orthodontic treatment
  • No sex predilection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

RECRUITING

Related Publications (12)

  • Alhammadi MS, Halboub E, Fayed MS, Labib A, El-Saaidi C. Global distribution of malocclusion traits: A systematic review. Dental Press J Orthod. 2018 Nov-Dec;23(6):40.e1-40.e10. doi: 10.1590/2177-6709.23.6.40.e1-10.onl.

    PMID: 30672991BACKGROUND

  • Burhan AS, Nawaya FR. Dentoskeletal effects of the Bite-Jumping Appliance and the Twin-Block Appliance in the treatment of skeletal Class II malocclusion: a randomized controlled trial. Eur J Orthod. 2015 Jun;37(3):330-7. doi: 10.1093/ejo/cju052. Epub 2014 Oct 8.

    PMID: 25296729BACKGROUND

  • Caldwell S, Cook P. Predicting the outcome of twin block functional appliance treatment: a prospective study. Eur J Orthod. 1999 Oct;21(5):533-9. doi: 10.1093/ejo/21.5.533.

    PMID: 10565094BACKGROUND

  • Clark William J., Mahony Derek, 2018. heal talk A journal of clinical dentistry 11.

    BACKGROUND

  • Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available.

    PMID: 3422118BACKGROUND

  • Cozza P, Baccetti T, Franchi L, De Toffol L, McNamara JA Jr. Mandibular changes produced by functional appliances in Class II malocclusion: a systematic review. Am J Orthod Dentofacial Orthop. 2006 May;129(5):599.e1-12; discussion e1-6. doi: 10.1016/j.ajodo.2005.11.010.

    PMID: 16679196BACKGROUND

  • Ehsani S, Nebbe B, Normando D, Lagravere MO, Flores-Mir C. Short-term treatment effects produced by the Twin-block appliance: a systematic review and meta-analysis. Eur J Orthod. 2015 Apr;37(2):170-6. doi: 10.1093/ejo/cju030. Epub 2014 Jul 22.

    PMID: 25052373BACKGROUND

  • Elfeky HY, Fayed MS, Alhammadi MS, Soliman SAZ, El Boghdadi DM. Three-dimensional skeletal, dentoalveolar and temporomandibular joint changes produced by Twin Block functional appliance. J Orofac Orthop. 2018 Jul;79(4):245-258. doi: 10.1007/s00056-018-0137-1. Epub 2018 Apr 16.

    PMID: 29663034BACKGROUND

  • Linjawi AI, Abbassy MA. Dentoskeletal effects of the forsus fatigue resistance device in the treatment of class II malocclusion: A systematic review and meta-analysis. J Orthod Sci. 2018 Feb 15;7:5. doi: 10.4103/jos.JOS_80_17. eCollection 2018.

    PMID: 29765917BACKGROUND

  • Matthaios S, Tsolakis AI, Haidich AB, Galanis I, Tsolakis IA. Dental and Skeletal Effects of Herbst Appliance, Forsus Fatigue Resistance Device, and Class II Elastics-A Systematic Review and Meta-Analysis. J Clin Med. 2022 Nov 26;11(23):6995. doi: 10.3390/jcm11236995.

    PMID: 36498570BACKGROUND

  • O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524.

    PMID: 12970656BACKGROUND

  • Thiruvenkatachari B, Harrison JE, Worthington HV, O'Brien KD. Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children. Cochrane Database Syst Rev. 2013 Nov 13;(11):CD003452. doi: 10.1002/14651858.CD003452.pub3.

    PMID: 24226169BACKGROUND

MeSH Terms

Conditions

MalocclusionMalocclusion, Angle Class IIMicrognathism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
primary investigator, assistant lecturer

Study Record Dates

First Submitted

July 6, 2023

First Posted

August 15, 2023

Study Start

December 1, 2022

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

results and statistical data would be published and IPD would be available upon request

Locations

EG(1)