NCT06638983

Brief Summary

Introduction: The investigators aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

October 7, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

Non-extractionorthodontics treatmentAngle class I malocclusion

Outcome Measures

Primary Outcomes (1)

  • We aimed to evaluate the effectiveness of non-extraction orthodontic treatment for Angle class I malocclusion.

    Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment

    Cephalometric radiographs, and extraoral and intraoral photographs, cast impressions and PAR Index (Peer Assessment Rating) were collected before and after intervention through study completion, an average of 2 years

Study Arms (1)

Cephalometric radiographs and cast impressions were collected before and after intervention.

OTHER

Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment.

Other: Non-extraction Orthodontic Treatment of Angle Class I Malocclusion

Interventions

Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment. Also the following soft tissue and bone indexes were assessed before and after intervention

Cephalometric radiographs and cast impressions were collected before and after intervention.

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients (≥ 15 years) with indicated Angle class I malocclusion and missing space ≤9mm
  • Cervical vertebral maturation stages 5, 6, (CS5, CS6): cervical vertebrae 2, 3, and 4 have a concave curved lower border and have at least one rectangle C3, C4 cervical vertebra upright or at least square
  • No prior orthodontic treatment
  • Fully erupted permanent teeth (except third molars)
  • Voluntary research participation

You may not qualify if:

  • Face soft tissue surgical procedures, periodontal disease, and maxillofacial congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, 900000, Vietnam

Location

Related Publications (1)

  • Baik KM, Anbar G, Alshaikh A, Banjar A. Effect of Social Media on Patient's Perception of Dental Aesthetics in Saudi Arabia. Int J Dent. 2022 Feb 27;2022:4794497. doi: 10.1155/2022/4794497. eCollection 2022.

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Diem Chau Hong, DDS

    Can Tho University of Medicine and Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Cephalometric radiographs, and extraoral and intraoral photographs, and cast impressions were collected before and after intervention. The weighted PAR Index (Peer Assessment Rating) employed to determine outcome of orthodontic treatment. Also the following soft tissue and bone indexes were assessed before and after intervention, SNA, SNB, ANB, SN\_GoGn, SN\_Occplane, U1\_NAmm, U1\_NA, L1\_NBmm, L1\_NB, U1\_L1, U1\_Mp, Ls\_E, Li\_E, and Nasolabial\_angle. Intervention was MBT (MBT System, 3M Unitek, USA) non-extraction fixed orthodontic treatment. One experienced researcher analyzed and interpreted all of the cephalometric images used in the study using the WedCeph (https://webceph.com/). Data were analyzed by linear regression and T-Test statistical test using R software version 4.3.0 (R Foundation for Statistical Computing, Vienna, Austria) by a blinded statistician.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 15, 2024

Study Start

May 20, 2020

Primary Completion

May 20, 2022

Study Completion

June 15, 2022

Last Updated

October 15, 2024

Record last verified: 2020-05

Locations