Skip to main content
Clinical Trials/NCT03655938
NCT03655938CompletedPhase 4

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

University of Liege1 site in 1 country10 target enrollmentStarted: March 20, 2017Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Radiographic change from Baseline and after 1year

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
  • •Mental or motor disabilities
  • •Pregnancy

Outcomes

Primary Outcomes

Radiographic change from Baseline and after 1year

Time Frame: 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

Secondary Outcomes

  • Periodontal Evaluation(Baseline and after 1 year)
  • Patient assessment(Baseline and after 1year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. France LAMBERT

Professor

University of Liege

Study Sites (1)

Loading locations...

Similar Trials