Amount of Root Resorption of Maxillary Anteriors After en... | NCT05606185

Studies
Amount of Root Resorption of Maxillary Anteriors After en Masse Versus Two Step Space Closure

NCT05606185

Sponsor

Dow University of Health Sciences

Status

Unknown status

Last Update Posted

Nov 4, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Root Resorption

Interventions

retraction method

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2019Actual

Primary Completion Date

Nov 2022Estimated

Completion Date

Nov 2022Estimated

First Submitted Date

Oct 31, 2022

First Submission Date that Met QC Criteria

Oct 31, 2022

First Posted Date

Nov 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2022

Last Update Posted Date

Nov 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
retraction method	Procedure	Three dimensional evaluation of root resorption using cone beam computed tomography	En masse retraction Two step retraction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Root resorption	Amount of root resorption in three dimensions	8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HIBA Tabassum, MDS	Dow University of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dow University of Health Sciences		Karachi	Sindh	75530	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012391	Root Resorption

Ancestor Terms

ID	Term
D014091	Tooth Resorption
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided