OHRQoL and Accelerated Orthodontics With Micro-osteoperforations

January 22, 2018 updated by: LIANA FATTORI ABATI, University of Sao Paulo

OHRQoL Assessment Between Sliding Anterior Retraction and Micro-osteoperforations for Accelerated Orthodontics in Patients Who Were Assigned for Pre-molar Extraction and Decompensation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our patients are participants in a randomized clinical trial, an ongoing study about the effectiveness of micro-osteoperforations to accelerate tooth movement. The study sample consisted of 22 consecutive subjects - 12 females and 10 males - between the ages of 18 and 35, who were selected for ortho-surgical treatment and pre-molar extraction assigned for decompensation. The participants were randomly allocated to two groups: control (anterior retraction was performed using implant-assisted sliding mechanics with self-ligating brackets) and experimental (micro-osteoperforations were performed in the activation appointments for anterior retraction using implant-assisted sliding mechanics). For immediate and follow-up assessment of patients' perceptions, comparing regular orthodontic activation and activation with Accelerated Orthodontics, subjects were asked to complete an electronic questionnaire OHIP-14, to assess the participants' comfort level, experiences, and QoL impact.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05508000
        • FOUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • any tooth absence/previous tooth extraction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Micro-osteoperforations
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
Three vertical micro-osteoperforations, using Excellerator, in the buccal extracted site were executed following the aseptic procedure and local anesthesia
No Intervention: Control
Anterior retraction after premolars extraction will be done conventionally (sliding mechanics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparision of OHRQoL between groups - OHIP-14A
Time Frame: 4 days
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
Time Frame: 4 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

October 21, 2017

Study Completion (Actual)

December 12, 2017

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fattori3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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