NCT06032702

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 5, 2023

Last Update Submit

September 5, 2023

Conditions

Orthodontic Tooth MovementTooth Alignment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

tooth alignmentPROCEDURE

Alignment will be assessed by Little's Irregularity Index

3 week interval6 week interval

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakhtawar Amin Medical And Dental College

Multan, Punjab Province, 66000, Pakistan

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

June 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

PA(1)