NCT06928896

Brief Summary

Objective:To evaluate the effectiveness of the friction (sliding mechanism with elastomeric chains) and frictionless (T-loop) methods for retracting anterior teeth in Angle Class I malocclusion. Methods: This clinical intervention study examined the duration of maxillary incisor retraction from August 2022 to August 2024 in 42 adult patients who had completed canine retraction. The process involved resolving horizontal and vertical discrepancies, establishing a Class I relationship between the canines, and altering the overbite (the interproximal space between the lateral incisors and canines) until an ideal overbite index of 2 mm was achieved. Cone beam computed tomography (CBCT) was conducted before and after retraction to evaluate alveolar changes and speed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

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

August 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
Last Updated

April 15, 2025

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 15, 2024

Last Update Submit

April 8, 2025

Conditions

Keywords

alveolar bone, elastomeric chains, friction, frictionless

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effectiveness of the friction (sliding mechanism with elastomeric chains) and frictionless (T-loop) methods for retracting anterior teeth in Angle Class I malocclusion.

    This interventional trial enrolled a total of 42 patients, dividing them into two age groups: group 1. Using the friction (sliding mechanism-elastomeric chains) and group 2. Using the frictionless (T-loop). For each patient, cone beam computed tomography (CBCT) was taken before and after retraction to evaluate alveolar changes. Study variables measured on CBCT. The palatal plane (PP) represents the magnetic connection between the PNS (posterior nasal spine) and the ANS (anterior nasal spine), V: a vertical reference line perpendicular to the ANS-PNS line, H: a vertical reference line parallel to the ANS-PNS line. Four lines perpendicular to the V line (L0, L1, L2, L3, 2 mm apart). Line L0 passes through the cementoenamel junction (CEJ) on the buccal side. Measure the alveolar bone thickness at 3 positions (S1, S2, S3, lingual, and buccal) at T1 and T2.

    6 months after enrollment

Study Arms (2)

Group 1. Using the friction

EXPERIMENTAL
Procedure: This interventional trial enrolled a total of 42 patients, dividing them into two age groups: group 1. Using the friction and group 2. Using the frictionless

Group 2. Using the frictionless

EXPERIMENTAL
Procedure: This interventional trial enrolled a total of 42 patients, dividing them into two age groups: group 1. Using the friction and group 2. Using the frictionless

Interventions

Cone beam computed tomography (CBCT) was conducted before and after retraction to evaluate alveolar changes and speed.

Group 1. Using the frictionGroup 2. Using the frictionless

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Angle class I malocclusion on one or both sides
  • Without any previous orthodontic treatment
  • Indications for fixed appliances, premolar extraction to create space during treatment
  • Consented to participate in the study

You may not qualify if:

  • History of craniofacial traumas, anomalies, congenital defects, or systemic diseases related to osteogenic metabolisms, e.g. diabetes mellitus, kidney diseases, osseous diseases
  • Patients took anticoagulant drugs that affected bone metabolism (eg., for example, heparin, warfarin, NSAIDs, cyclosporine, glucocorticoids, medroxyprogesterone acetate, etc.)
  • Mini screw, and hook failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, Can Tho City, 90000, Vietnam

Location

Related Publications (1)

  • Vazquez E. Saquinavir plus ritonavir reduce viral load by 99.9 percent. Posit Aware. 1996 Nov-Dec;7(6):8-9.

    PMID: 11363983BACKGROUND

Related Links

MeSH Terms

Conditions

Malocclusion, Angle Class IAlveolar Bone Loss

Interventions

Population Groups

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Odonto-Stomatology

Study Record Dates

First Submitted

October 15, 2024

First Posted

April 15, 2025

Study Start

August 1, 2022

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

April 15, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations