NCT04878939

Brief Summary

There's scarcity in literature concerning the issue of anterior segment retraction technique and its effect on anterior teeth position. Therefore, a randomized clinical trial has been chosen to investigate this issue, aiming to support clinicians with the best guidelines for anterior segment retraction.

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 2019

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 4, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

April 25, 2021

Last Update Submit

May 5, 2021

Conditions

Bimaxillary Protrusion

Keywords

frictionfrictionlessCBCTanterior segment retractionT loop

Outcome Measures

Primary Outcomes (3)

  • Torque of the incisors

    The change of the outer angle between long axis of each upper anterior tooth and palatal plane on CBCT pre and post retracation and the change in the outer angle between long axis of each lower anterior tooth and horizontal plane on CBCT pre and post retracation

    through study completion (Pre/post retraction), an average of 6 months

  • Tip of the incisors

    The change of the angle between the long axis of the incisors and mid-sagittal plane on CBCT pre and post retracation

    through study completion (Pre/post retraction), an average of 6 months

  • Vertical changes of the incisors

    The change of the linear distance between the centroid of each maxillary anterior tooth and palatal Plane on CBCT pre and post retracation and The change of the linear distance between centroid of each mandibular anterior tooth and horizontal Plane on CBCT pre and post retracation

    through study completion (Pre/post retraction) , an average of 6 months

Secondary Outcomes (1)

  • Root resorption of the anterior teeth

    through study completion (Pre/post retraction), an average of 6 months

Study Arms (2)

Anterior segment retraction using sliding mechanics (friction)

EXPERIMENTAL

Power chain

Other: Power chain used for anterior segment retraction

Anterior segment retraction using segmental mechanics (frictionless)

EXPERIMENTAL

T-loop

Other: T-loop fabricated to perform anterior segment retraction

Interventions

Power chain used for anterior segment retractionOTHER

Elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor.

Anterior segment retraction using sliding mechanics (friction)
T-loop fabricated to perform anterior segment retractionOTHER

In the frictionless group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force.

Anterior segment retraction using segmental mechanics (frictionless)

Eligibility Criteria

Age13 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female patients (Age 13- 25 y)
  • Class I molar relation (Angle's classification)
  • Bimaxillary protrusion requiring extraction of four first premolars and maximum anchorage.
  • full permanent dentition (except 3rd molars)
  • Good general and oral health

You may not qualify if:

  • Systemic disease or syndromes or on anti-inflammatory medication.
  • Extracted or missing permanent teeth (other than 3rd molars)
  • Badly decayed teeth (other than 1st premolars)
  • Parafunctional habits
  • History of previous orthodontics treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future University in Egypt

Cairo, Egypt

Location

Related Publications (1)

  • Bakhit DMI, Tawfik MGY, Dehis HM, Mostafa YA, El Sharaby FA. Position and root resorption of the incisors following anterior segment retraction using friction versus frictionless mechanics: A randomised controlled trial. J Orthod. 2025 Mar;52(1):12-21. doi: 10.1177/14653125241261402. Epub 2024 Jul 25.

    PMID: 39049618DERIVED

Study Officials

  • Yehia Mostafa, Professor and Chairman

    Future University in Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of the main investigator to the interventions was difficult, yet the outcome assessor was masked to the intervention and assessed unidentified CBCTs
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2021

First Posted

May 10, 2021

Study Start

February 4, 2019

Primary Completion

September 1, 2020

Study Completion

December 13, 2020

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be ready to share after publication

Locations

EG(1)