NCT03407261

Brief Summary

OHRQoL assessment using OHIP-14 between sliding anterior retraction with self-ligating brackets and micro-osteoperforations for accelerated orthodontics in orthognathic surgery patients who were assigned for pre-molar extraction and decompensation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 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

June 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

January 16, 2018

Last Update Submit

January 22, 2018

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (2)

  • Comparision of OHRQoL between groups - OHIP-14A

    comparision of OHIP-14A results between groups after appointment for anterior retraction: The sum of the numeric scores for each participant in all 14 items, with a maximum score of 56 (4x14);

    4 days

  • Comparision of OHRQoL between groups - 7 domains

    comparision of each OHIP-14 domain results between groups after appointment for anterior retraction: To evaluate which domains had the most impact during the trial, the answers for each question were combined as pairs and summed for statistical analysis.

    4 days

Study Arms (2)

Micro-osteoperforations

EXPERIMENTAL

Minimally invasive micro-osteoperforations procedure used to achieve accelerated orthodontic tooth movement. Topical and local anesthetic will be delivered in the area to be treated in accordance with standard practice

Procedure: micro-osteoperforations

Control

NO INTERVENTION

Anterior retraction after premolars extraction will be done conventionally (sliding mechanics)

Interventions

micro-osteoperforationsPROCEDURE

Three vertical micro-osteoperforations, using Excellerator, in the buccal extracted site were executed following the aseptic procedure and local anesthesia

Micro-osteoperforations

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • maxillomandibular discrepancy indicative for orthognathic surgery, no previous dental extractions, good oral and general health, non-smokers, and no use of systemic corticosteroids or biphosphonates

You may not qualify if:

  • any tooth absence/previous tooth extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FOUSP

São Paulo, 05508000, Brazil

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 23, 2018

Study Start

June 15, 2017

Primary Completion

October 21, 2017

Study Completion

December 12, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

BR(1)