Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration

Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration : a Prospective Study

This study was designed to enroll a series of 10 consecutive patients who met the inclusion criteria. Patients were treated in the Department of Orthodontics and Dento-Facial Orthodopedics of the University of Liège. Two senior's orthodontists and two senior's periodontists were involved in the orthodontic treatment and in the surgical procedures respectively. All clinical, radiographic and periodontal measurements and all orthodontic parameters were performed at baseline and after the orthodontic treatments. Tree examiners collected the overall data.

Study Overview

• Status: Completed
• Conditions: Patients Requiring Mandible Orthodontic Treatment
• Intervention / Treatment: Procedure: Piezocision combined minimally invasive alveolar bone regeneration

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU University of Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients requiring at least mandible orthodontic treatment (both arches)
• Patient presenting alveolar bone thickness < XX mm
• Adult patients with completed growth based on the Cervical Vertebral Maturation Method (CVM) as described by Baccetti et al. (Baccetti et al. 2002)
• Minimal to moderate mandibular anterior crowding at baseline (irregularity index≤6) (Little 1975)
• American Society of Anesthesiology I or II (I = Normal healthy patient; II = Patients with mild systemic disease)
• Adequate dento-oral health (i.e., the absence of periodontal diseases, peri-apical infection, or untreated caries).

Exclusion criteria were as follows:

• Controlled periodontitis with a loss of alveolar support > 10%
• Gingival recession > 2 mm
• Smokers
• Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
• Mental or motor disabilities
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic change from Baseline and after 1year	The patients underwent baseline and post treatment CBCT scans (Somaton® Emotion; Siemens, Munich, Germany). Measurements of the alveolar bone changes in the lower front region on pre- and post- treatment CT volumes were done by reformatting the orthogonal slices, along the sagittal, coronal and axial length axes of each individual tooth. A strict vestibular bone level measurement (sagittal slice) and three alveolar bone width measurements at crestal level, 3mm from the crest and 6mm from the crest (axial slices) were performed per individual tooth. In addition, CT images were analyzed in using a dedicated platform in an image processing software (MeVisLab, MeVis Medical Solutions AG, Bremen,Germany) where pre- and post-treatment volumes were superposed using rigid image registration. Semi-automatically segmentation using region growing with same seed-point and threshold value for both scans, was followed with a hole-filling algorithm to obtain segmented volumes of the cropped image in	Baseline and after 1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal Evaluation	The following clinical parameters were measured at baseline and after the orthodontic treatments: recession depths (RDs), pocket depth, plaque index (PI) and papilla bleeding index (PBI). A recession score was calculated by summing the recession depths. Next, the presence of gingival scars due to the overall treatment of each patient was categorized as an absence of scars, point-shape scars or linear-shape scars. Full periodontal charting (probing in four sites per tooth) was performed in all patients before and after the treatment; the results were expressed as score per sextant.	Baseline and after 1 year
Patient assessment	The patient-centered outcomes were recorded using a Visual Analog Scale questionnaire that employed a 0-10 graduated scale. The following parameters were collected: apprehension before treatment (scale ranges, minimum=0 and maximum=10) scores), pain level after treatment and daily analgesic consumption following orthodontic appliance placement and piezocision (scale ranges, minimum=0 and maximum=10). After the overall treatment, the levels of satisfaction in terms of the final result (scale ranges, minimum=0 and maximum=10), the treatment duration and whether the patient would recommend the procedure to a friend were assessed (scale ranges, Yes=0 and No=10). Finally, the patients were asked whether they would undergo the treatment again (scale ranges, Yes=0 and No=10).	Baseline and after 1year

Collaborators and Investigators

• Sponsor: University of Liege

Publications and helpful links

General Publications

• Charavet C, Lecloux G, Vandenberghe B, Lambert F. Buccal bone regeneration combined with piezocision in adult orthodontic patients: Clinical, 3D radiographic, and patient-reported outcomes. J Stomatol Oral Maxillofac Surg. 2021 Dec;122(6):549-556. doi: 10.1016/j.jormas.2020.10.005. Epub 2020 Oct 22.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: P2016-1 In-OP WP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No