NCT05606185

Brief Summary

The goal of this study is to compare the three dimensional root resorption after extraction space closure in two groups: two step retraction and en masse retraction. Th main aim of this study is to conclude which method is less damaging to the roots. Participants will be divided into two groups:

  1. 1.En masse retraction (experimental)
  2. 2.Two step retraction (control) Pre retraction and post retraction CBCT scans will be compared for both groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 9, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
Last Updated

November 4, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

October 31, 2022

Last Update Submit

October 31, 2022

Conditions

Keywords

Two step retractionEn masse retractionCone Beam Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • Root resorption

    Amount of root resorption in three dimensions

    8 months

Study Arms (2)

Two step retraction

ACTIVE COMPARATOR

teeth will be retracted in two stages

Procedure: retraction method

En masse retraction

EXPERIMENTAL

teeth will be retracted in one stage

Procedure: retraction method

Interventions

Three dimensional evaluation of root resorption using cone beam computed tomography

En masse retractionTwo step retraction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who signed the informed consent to be part of this study.
  • Patients with Class I or Class II malocclusion.
  • Patients requiring extractions of maxillary first premolars with absolute anchorage.
  • Good periodontal status.

You may not qualify if:

  • Patients who are syndromic or have cleft lip and/or palate.
  • Patients with severe root dilacerations or root canal treated incisors.
  • Patients receiving drugs that alter tooth movement.
  • Patients with systemic disease like endocrinological disorders, vit D excess or deficiency, thyroid or parathyroid problems.
  • Patients with history of trauma to dentition or impacted teeth in anterior maxilla.
  • Patients who have undergone previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75530, Pakistan

Location

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Officials

  • HIBA Tabassum, MDS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 4, 2022

Study Start

December 9, 2019

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

November 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations