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

Sponsor

Bkahtawar Amin Medical and Dental College Multan (Other)

Overall Status

Recruiting

CT.gov ID

NCT06032702

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Tooth Movement Tooth Alignment	Procedure: tooth alignment	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3 week interval 3 week orthodontic interappointment interval	Procedure: tooth alignment Alignment will be assessed by Little's Irregularity Index
Experimental: 6 week interval 6 week orthodontic interappointment interval	Procedure: tooth alignment Alignment will be assessed by Little's Irregularity Index

Arm

Intervention/Treatment

Experimental: 3 week interval

3 week orthodontic interappointment interval

Procedure: tooth alignment

Alignment will be assessed by Little's Irregularity Index

Experimental: 6 week interval

6 week orthodontic interappointment interval

Procedure: tooth alignment

Alignment will be assessed by Little's Irregularity Index

Outcome Measures

Primary Outcome Measures

alignment efficiency and interappointment interval [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]
Changes in Little's Irregularity Index between arm 1 and arm 2 and comparison of both interventions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakhtawar Amin Medical And Dental College	Multan	Punjab	Pakistan	66000

Sponsors and Collaborators

Bkahtawar Amin Medical and Dental College Multan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bkahtawar Amin Medical and Dental College Multan

ClinicalTrials.gov Identifier:

NCT06032702

Other Study ID Numbers:

BAMDC 0001

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 13, 2023