Micro-osteoperforations on the Rate of Canine Retraction | NCT04968327

Studies
Micro-osteoperforations on the Rate of Canine Retraction

NCT04968327

Sponsor

Hams Hamed Abdelrahman

Status

Completed

Last Update Posted

Jul 20, 2021Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Malocclusion

Interventions

Micro-osteoperforations (MOPs)
Conventional canine retraction

Countries

Egypt

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Aug 18, 2017Actual

Completion Date

Aug 30, 2017Actual

First Submitted Date

Jul 5, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 20, 2021Actual

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

Jul 8, 2021

Last Update Posted Date

Jul 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria UniversitySponsor-Investigator

Lead Sponsor

Hams Hamed AbdelrahmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction.

Detailed Description

Ten adult patients requiring maxillary first premolars' extraction were enrolled in this split-mouth randomized controlled clinical trial.

Micro-osteoperforations were randomly assigned to one side of the maxillary arch at the canine-premolar region, and the contralateral side served as the control.

Mini-screws were used for anchorage reinforcement, and canine retraction was performed using nickel-titanium closed coil springs, delivering a force of 150 grams per side.

The primary outcome was the measurement of canine retraction rate throughout the study period from digital dental models obtained every 3 weeks.

The secondary outcome was the detection of possible canine tipping during retraction.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Micro-osteoperforations	Experimental		Other: Micro-osteoperforations (MOPs) Other: Conventional canine retraction
Canine retraction	Active Comparator		Other: Conventional canine retraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micro-osteoperforations (MOPs)	Other	MOPs included shallow perforations of the buccal cortical plate surrounding the tooth that requires orthodontic tooth movement, with no flap reflection was performed using a surgical bur using the special calibrated device called PROPEL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of canine retraction	measurements were recorded from digital dental models every 3 weeks	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Measurment of canine tipping	Tipping of the maxillary canine during retraction was also evaluated from digital dental models	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy systemic condition with no chronic diseases
no previous orthodontic treatment
adequate oral hygiene
have a healthy periodontium
signed an informed consent

Exclusion Criteria:

have a chronic disease
previous orthodontic treatment
poor oral hygiene or periodontal conidition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria Faculty of Dentistry		Alexandria			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D008310	Malocclusion

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided