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

September 5, 2023 updated by: Bkahtawar Amin Medical and Dental College Multan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

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

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 66000
        • Recruiting
        • Bakhtawar Amin Medical And Dental College
        • Contact:
          • Waqar Jeelani, BDS,FCPS, MOrth-Edin UK
          • Phone Number: 00923457936578
          • Email: wjeelani@gmail.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alignment efficiency and interappointment interval
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bkahtawar Amin Medical and Dental College Multan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BAMDC 0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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