Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06589206

Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance

The aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

10 year–14 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Twin block appliance is the gold standard for the treatment of skeletal class II patients with deficient mandible. Yet, it has some drawbacks as proclination of the mandibular incisors, development of posterior open bite and the unesthetic appearance. Many modifications in twin block A new design were made to overcome the previous problems, as adding incisor capping, Clasps, sagittal blocks, and esthetic twin block appliances. In the current trial A new design of esthetic twin block appliance with sagittal blocks is investigated and the post treatment skeletal, dental, and soft tissue, TMJ, and upper airway size will be assessed and compared to the changes associated with the conventional design of twin block. Moreover, patient satisfaction with the appliance will be assessed with both appliances.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • skeletal class II deficient mandible
  • Class II molar and canine relation
  • male growing patients CVM 2,3 age range 10-14
  • normal vertical growth pattern
  • ANB > 4
  • mild to moderate crowding

Exclusion criteria

  • Previous orthodontic treatment.
  • Craniofacial syndrome.
  • Periodontal disease.
  • Extracted first permanent molars.

Treatment and study plan

modified design of twin block

Other

Vacuum formed twin block appliance with sagittal blocks

Primary outcomes

  1. skeletal changes

    Time frame: 9 months

    changes in SNA, SNB, and ANB angles will be measured before and after treatment

  2. Dental changes

    Time frame: 9 months

    changes in maxillary and mandibular incisors position and inclination will be assessed before and after treatment

Secondary outcomes

  1. soft tissue changes

    Time frame: 9 months

    changes in soft tissue A, B, Pog points will be assessed before and after treatment

  2. JMJ changes

    Time frame: 9 months

    changes in the TMJ morphologic structure will be assessed before and after treatment

  3. Upper airway size

    Time frame: 9 months

    changes in the Upper airway size will be assessed before and after treatment

  4. patient satisfaction

    Time frame: after one and nine months

    patients acceptance of the appliance will be assessed by a questionnaire administered in one to one interview.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance for Treatment of Skeletal Class II Growing Patients With Mandibular Deficiency: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.