NCT05542745

Brief Summary

Few studies had investigated the effectiveness of segmental retraction. As a result of that, this study was concerned about comparing retraction rate of maxillary incisors between buccal and palatal mini-implant supported retraction groups in Class II division 1 non growing patients for 3 months interval.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

September 11, 2022

Last Update Submit

September 13, 2022

Conditions

Class II Division 1 Malocclusion

Keywords

Orthodontics, incisors retraction, mini-implants, direct- anchorage.

Outcome Measures

Primary Outcomes (1)

  • rate of retraction

    distance travelled at specific time interval

    3 months

Study Arms (2)

palatal retractor

ACTIVE COMPARATOR

palatal retraction

Device: palatal and buccal retraction

buccal retractor

ACTIVE COMPARATOR

buccal retraction

Device: palatal and buccal retraction

Interventions

palatal and buccal retractionDEVICE

comparison

buccal retractorpalatal retractor

Eligibility Criteria

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

You may qualify if:

  • \. Class II division 1 malocclusion with no or mild crowding 2. Age ranging from 14 to 18 years.

You may not qualify if:

  • No previous orthodontic therapy of any type prior to this treatment No systematic disease Good oral hygiene and no periodontal problems No abnormal oral habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egypt

Al Mansurah, +20, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • ElBialy

    Faculty of Dentistry Mansoura Univesity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2022

First Posted

September 15, 2022

Study Start

February 20, 2020

Primary Completion

March 26, 2021

Study Completion

July 14, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

EG(1)