NCT05433051

Brief Summary

this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry.

Trial Health

55
Monitor

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 Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

June 22, 2022

Last Update Submit

May 21, 2024

Conditions

Dental IntrusionMandibular RotationANB , SNA, SNBOpenbite Teeth | Teeth and Gum | Dental

Keywords

TPAMiniscrewintrusionvertical holding appliancecephalometry

Outcome Measures

Primary Outcomes (3)

  • amount of dental

    rate of maxillary molar intrusion by cephalometry

    Post-intervention at 6 months

  • amount of skeletal changes

    amount of vertical overlap by cephalometry

    Post-intervention at 6 months

  • amount of skeletal changes

    amount of mandibular rotation by cephalometry

    Post-intervention at 6 months

Study Arms (2)

Buccal miniscrews with TPA

ACTIVE COMPARATOR

active comparator double center

Biological: buccal miniscrew and TPA

vertical holding appliance

ACTIVE COMPARATOR

active comparator double center

Biological: vertical holding appliance

Interventions

buccal miniscrew and TPABIOLOGICAL

intrusion of molars

Buccal miniscrews with TPA
vertical holding applianceBIOLOGICAL

intrusion of molars

vertical holding appliance

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients suffering class I or II with AOB.
  • AOB ranged between 3-7 mm assessed from cephalometry.
  • Patients with excess in posterior dentoalveolar height according to Burrstone .
  • Patients with good oral hygiene and general health.
  • Patients with no previous orthodontic treatment.
  • Good quality of lateral cephalometry.

You may not qualify if:

  • Skeletal open bite
  • previous orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Shendy

Cairo, Nasr City, 002, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 27, 2022

Study Start

April 10, 2022

Primary Completion

October 10, 2024

Study Completion

October 30, 2024

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

EG(1)