NCT06589206

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 24, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

August 24, 2024

Last Update Submit

September 15, 2024

Conditions

Growth Modification

Keywords

twin blockesthetic twin blockclear twin blockDeficient mandibleSkeletal Class II

Outcome Measures

Primary Outcomes (2)

  • skeletal changes

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

    9 months

  • Dental changes

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

    9 months

Secondary Outcomes (4)

  • soft tissue changes

    9 months

  • JMJ changes

    9 months

  • Upper airway size

    9 months

  • patient satisfaction

    after one and nine months

Study Arms (2)

conventional twin block

ACTIVE COMPARATOR

Growing patients with class II skeletal discrepancy due to mandibular deficiency will be treated with the conventional design of twin block previously introduced by Clark.

Other: modified design of twin block

Vacuum formed twin block appliance with sagittal blocks

EXPERIMENTAL

Growing patients with class II skeletal discrepancy due to mandibular deficiency will be treated with a modified design of twin block formed of vacuum sheets with sagittal blocks.

Other: modified design of twin block

Interventions

modified design of twin blockOTHER

Vacuum formed twin block appliance with sagittal blocks

Vacuum formed twin block appliance with sagittal blocksconventional twin block

Eligibility Criteria

Age10 Years - 14 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Assistant

Study Record Dates

First Submitted

August 24, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09