Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration

NCT ID: NCT03655938

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2018-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Patients Requiring Mandible Orthodontic Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Piezocision combined minimally invasive alveolar bone regeneration

The piezocision surgery was performed two weeks after orthodontic appliance placement. The patients received local anesthesia in mandibular arch and vertical interproximal incisions were made below the interdental papillae in the midline, from the mesial aspect of each canine and in between each of the posterior lower teeth. The periostium was then released in order to create two subperiotal envelopes connecting the vertical incisions together. Thereafter, corticotomies were performed in the region of the incisions with a piezotome (Acteon, Merignac, France) and the envelopes were filled with a beta tricalcium phosphate, a resorbable biomaterial in order to thicken the buccal bone plate. Resorbable 5-0 sutures were used to close the flaps. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days.

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Dr. France LAMBERT

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU University of Liège

Liège, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 33289660 (View on PubMed)

Other Identifiers

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P2016-1 In-OP WP2

Identifier Type: -

Identifier Source: org_study_id