OHRQoL and Accelerated Orthodontics With Micro-osteoperforations

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407261
• Other study ID #: Fattori3
• Status: Completed
• Phase: N/A
• First received: January 16, 2018
• Last updated: January 22, 2018
• Start date: June 15, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: January 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 12, 2017
• Est. primary completion date: October 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

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

Locations

Country	Name	City	State
Brazil	FOUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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