Effect of 3 Week vs 6 Week Orthodontic Appointment Interv... | NCT06032702

Studies
Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment

NCT06032702

Sponsor

Bkahtawar Amin Medical and Dental College Multan

Status

Unknown status

Last Update Posted

Sep 13, 2023Actual

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Orthodontic Tooth Movement
Tooth Alignment

Interventions

tooth alignment

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Nov 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Sep 5, 2023

First Submission Date that Met QC Criteria

Sep 5, 2023

First Posted Date

Sep 13, 2023Actual

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

Sep 5, 2023

Last Update Posted Date

Sep 13, 2023Actual

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

Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients with moderate to severe dental crowding: a randomized clinical trial.

There is still inconclusive evidence about the orthodontics treatment duration and interappointment interval.

Detailed Description

Patients with moderate to severe crowding will be divided randomly into two groups (Group A and Group B). Group A includes patients with an interval of 3 weeks between their appointments while Group B includes the patients with an interval of 6 weeks between their appointments.

To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 3rd week
To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 6th week
To compare the difference between the two modalities in percentage

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

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3 week interval	Experimental	3 week orthodontic interappointment interval	Procedure: tooth alignment
6 week interval	Experimental	6 week orthodontic interappointment interval	Procedure: tooth alignment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tooth alignment	Procedure	Alignment will be assessed by Little's Irregularity Index	3 week interval 6 week interval

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
alignment efficiency and interappointment interval	Changes in Little's Irregularity Index between arm 1 and arm 2 and comparison of both interventions.	Time frame for measurement of (Little's Irregularity Index) was every 6th week over a period of 6 months, giving a total of 5 measurements

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 16-30
Little's irregularity index from 5mm to 12mm
Healthy periodontium
No systemic disease
Patients giving consent for inclusion

Exclusion Criteria:

Little's irregularity index less than 5mm and more than 12mm
Blocked out incisors needing push coil
Ankylosed teeth
Active periodontal disease
Systemic bone disease
Non-compliant patients
Patients with frequent breakages

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

30 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
Bakhtawar Amin Medical And Dental College	Recruiting	Multan	Punjab Province	66000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided