NCT04468295

Brief Summary

The study compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

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

First Submitted

Initial submission to the registry

July 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 9, 2020

Last Update Submit

July 10, 2020

Conditions

Orthodontic Tooth Movement

Outcome Measures

Primary Outcomes (1)

  • Retraction Rate

    The rate of en-masse retraction of the anterior teeth

    6 months

Study Arms (2)

0.018-inch slot orthodontic bracket system

EXPERIMENTAL

En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.

Procedure: BondingProcedure: Leveling and alignmentProcedure: ExtractionProcedure: RetractionProcedure: Digital modelsProcedure: measurement

0.022-inch slot orthodontic bracket system

ACTIVE COMPARATOR

En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.

Procedure: BondingProcedure: Leveling and alignmentProcedure: ExtractionProcedure: RetractionProcedure: Digital modelsProcedure: measurement

Interventions

BondingPROCEDURE

Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch

0.018-inch slot orthodontic bracket system0.022-inch slot orthodontic bracket system
Leveling and alignmentPROCEDURE

Leveling and alignment till 0.016 x0.022 Ni Ti

0.018-inch slot orthodontic bracket system0.022-inch slot orthodontic bracket system
ExtractionPROCEDURE

Extraction of maxillary 1st premolars

0.018-inch slot orthodontic bracket system0.022-inch slot orthodontic bracket system
RetractionPROCEDURE

En-masse retraction using 0.017x0.025 TMA T loop

0.018-inch slot orthodontic bracket system0.022-inch slot orthodontic bracket system
Digital modelsPROCEDURE

impression taking and digital scanning

0.018-inch slot orthodontic bracket system0.022-inch slot orthodontic bracket system
measurementPROCEDURE

Assessment the rate of retraction for 6 months

0.018-inch slot orthodontic bracket system0.022-inch slot orthodontic bracket system

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Maxillary dentoalveolar protrusion cases that require upper first premolars extraction.
  • Full permanent dentition (not necessitating third molars).
  • Good oral hygiene.

You may not qualify if:

  • Patients having systemic diseases or on medications that would affect tooth movement.
  • Active periodontal disease or obvious bone loss in maxillary arch.
  • Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
  • Previous orthodontic treatment.
  • Missing teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 13, 2020

Study Start

September 28, 2020

Primary Completion

September 28, 2021

Study Completion

March 28, 2022

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share