NCT04921579

Brief Summary

Brief summary: there's a scarcity in literature concerning time needed to retract anterior segment following premolars extraction. the purpose of this study is to determine, in orthodontic patients with maxillary protrusion, which form of technique of retraction offers a faster treatment duration of retraction : en-masse or two step techniques

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 Dec 2019

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

December 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

May 31, 2021

Last Update Submit

June 8, 2021

Conditions

Bimaxillary Protrusion

Keywords

En-masse retractiontwo step retractionfrictionretraction timeDental models

Outcome Measures

Primary Outcomes (1)

  • Time to close extraction space

    the antero-posterior movement of anterior teeth are assessed by monthly taken models and patient record sheets

    from pre to post retraction ( an average of 10 - 12 months)

Secondary Outcomes (2)

  • Anchorage loss

    From pre to post retraction ( an average of 10- 12 months)

  • pain of intervention

    From pre to post retraction ( an average of 10 - 12 months)

Study Arms (2)

En masse retraction

EXPERIMENTAL

six anterior teeth are retracted by en masse technique using a crimpable hook distal to upper lateral incisor and a power chain.

Procedure: En masse retraction

two step retraction

EXPERIMENTAL

six anterior teeth are retracted by two step technique by canine retraction followed by four anterior teeth retraction using a crimpable hook distal to upper lateral incisor and a power chain.

Procedure: Two-Step retraction

Interventions

En masse retractionPROCEDURE

Retraction stated on a 0.017''x 0.025'' Stainless steel wire using elastomeric chain ( force applied 200 g per side) extending between the crimpable hooks and the mini-screw.

En masse retraction
Two-Step retractionPROCEDURE

Retraction of canine started on a 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 150 g per side) followed by anterior teeth retraction on 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 160 g per side) extending between crimpable hooks and the mini-screw.

two step retraction

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adults and adolescent patients ( both gender)
  • Age range (14- 24)
  • patient with maxillary protrusion requiring first premolars extraction ( bimaxillary protrusion or class II division 1 cases)
  • patients with fully erupted permanent teeth ( not necessarily including the third molar).
  • cases required maximum anchorage during retraction.
  • good general and oral health

You may not qualify if:

  • patients suffering from any systemic diseases interfering with tooth movement.
  • patients with extracted or missing permanent teeth (except for third molars).
  • patients with badly decayed teeth.
  • patients with any parafunctional habits ( i.e. Bruxism, tongue thrusting, mouth breathing, etc.,.....)
  • patients with previous orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future University

Cairo, 11835, Egypt

Location

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
single ( Outcomes Assessor) Only the outcome assessors will be blind. The patients name will be sealed from pre and post radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 10, 2021

Study Start

December 15, 2019

Primary Completion

January 21, 2021

Study Completion

January 21, 2021

Last Updated

June 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

All collected IPD sharing statement

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available after publication

Locations

EG(1)