NCT06554769

Brief Summary

Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

February 7, 2024

Last Update Submit

August 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • anchorage loss

    amount of anchorage loss of the upper first molar during canine retraction using digital model in mm.

    4 month

Secondary Outcomes (1)

  • vertical position of the upper second premolar

    4 month

Study Arms (2)

Non-Rigid connection

EXPERIMENTAL

side received a non-rigid 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew.

Procedure: non rigid indirect anchorage connection

Rigid Connection

ACTIVE COMPARATOR

rigid wire 19 x 25 inch stst wire was place between upper first molar and the miniscrew placed between the first molar and second premolar

Procedure: rigid indirect anchorage connection

Interventions

a nonrigid connection is placed between the miniscrews and the second premolar to prevent mesial tooth movement.

Non-Rigid connection

a rigid connection is placed between the miniscrews and the first molar to prevent mesial tooth movement.

Rigid Connection

Eligibility Criteria

Age13 Years - 23 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adult females Bimaxillary protrusion requiring first premolars extractions Full permanent dentition Good oral hygiene

You may not qualify if:

  • History of previous orthodontic treatment Abnormalities in teeth size and/or shape Vertical, transverse, or anteroposterior skeletal discrepancies Anti-inflammatory medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: split mouth randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 7, 2024

First Posted

August 15, 2024

Study Start

July 2, 2023

Primary Completion

February 1, 2024

Study Completion

June 2, 2024

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations