OHRQoL and Accelerated Orthodontics With Micro-osteoperforations

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Malocclusion

Intervention / Treatment
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* Procedure: micro-osteoperforations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |