AzTrials
AzTrials

MalocclusionNCT05993156

Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency

A study testing modified Fixed twinblock and removable twin block in people with Malocclusion and Angle Class II, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 9 to 15 years, women only
Conditions the study is for
Malocclusion, Angle Class II, Mandible Small
What is being tested?
modified Fixed twinblock and removable twin block
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
1 Dec 2022to 30 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 15 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting

  • Faculty of Dentistry

    Cairo

    ezat ahmed, 0020223642705, rec@dentistry.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

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

A Randomized Clinical Trial

Read the detailed description

The main objective of the study is to evaluate the effects of the modified fixed TB on class 2 growing cases and to compare its effect to the conventional removable TB

Research question Does the modified fixed twin block have the same effects as removable twin block during treatment of skeletal class 2 growing patients with mandibular deficiency?

PICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin block C: Conventional removable Twin block

O :

Primary outcome:

Overjet

Secondary outcome:

Soft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient Acceptance

Hypothesis:

There is no difference between the modified fixed or removable Twin block appliance regarding overjet reduction, dentoskeletal effects and patient perception.

  1. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.
Being tested
modified Fixed twinblock, removable twin block
Keywords
orthodontics, orthopedics, myofunctional appliance, Twinblock
Medical subject headings
Malocclusion, Malocclusion, Angle Class II, Micrognathism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modified Fixed twinblockDevice

    Also called F.T.B.

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

  • removable twin blockDevice

    Also called R.T.B.

    Conventional Removable Clark twin block myofunctional appliance

Study groups in NCT05993156
Study groupRoleWhat they receive
Removable twin block groupActive comparatorparticipants would receive conventional removable twin block for correction of class II malocclusion for 9 months
Receives: Device: removable twin block
Fixed twin block groupExperimentalparticipants would receive a modified fixed twin block for correction of class II malocclusion for 9 months
Receives: Device: modified Fixed twinblock

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Over jet reduction

    the horizontal distance between upper and lower incisors

    Measured: 9 months

Secondary outcomes (2)

  1. Effective mandibular length

    distance from condylon to the Pogonion points

    Measured: 9 months

  2. lower incisor inclination

    inclination of lower incisors on the mandibular plane

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2023
  2. Study start1 Dec 2022
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion30 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05993156
Sponsor's protocol ID
3-3-23
Status last verified
Aug 2023
First submitted
6 Jul 2023
Last updated
15 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: results and statistical data would be published and IPD would be available upon request

Publications

  • 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.

    PubMed 30672991

  • 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.

    PubMed 25296729

  • 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.

    PubMed 10565094

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

  • 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.

    PubMed 3422118

  • 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.

    PubMed 16679196

  • 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.

    PubMed 25052373

  • 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.

    PubMed 29663034

  • 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.

    PubMed 29765917

  • 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.

    PubMed 36498570

  • 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.

    PubMed 12970656

  • 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.

    PubMed 24226169

Questions about this trial

What is this clinical trial studying?

A study testing modified Fixed twinblock and removable twin block in people with Malocclusion and Angle Class II, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Over jet reduction (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05993156, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in