The Introduction of a Novel PAOO Technique

NCT05264480 | Completed DMC

• 1 other identifier: PIEZO-ORTHO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate in a prospective, randomized, controlled clinical trail the effectiveness of preorthodontic piezotomy combined with a buccal bone augmentation (in other name periodontlly accelerated osteogenic orthodontics: PAOO)in the prevention of gingival recession, and in the acceleration of orthodontic tooth movement (OTM).

Conditions

Bone Loss; Tooth Movement

Keywords

periodontally accelerated osteogenic orthodontics; orthodontic tooth movement; corticotomy; bone augmentation

Outcome Measures

Primary Outcomes (1)

• Speed of OTM

  The angle and distance of the movement of the middle incisor are measure on cephalogramms. The values are divided by the elapsed time frame in order to calculate the speed of OTM.

  From the date of orthodontic appliance bonding until the date of documented finalization of nivellation phase of OTM registered by the orthodontic specialist (in weeks), assessed up to maximum of 25 weeks.

Secondary Outcomes (2)

• Vertical bone level

  6 months postoperatively

• Horizontal bone levels

  6 months postoperatively

Study Arms (2)

Test group

EXPERIMENTAL

Test patients receive bone augmentation and selective decorticalisation (corticotomy) and 1 week postop. OTM.

Procedure: Bone augmentation with minimally invasive corticotomy (piezotomy)

Control group

ACTIVE COMPARATOR

Control subjects receive bone augmentation without decorticalisation (corticotomy) and 1 week postop. OTM.

Procedure: Bone augmentation without corticotomy

Interventions

Bone augmentation with minimally invasive corticotomy (piezotomy) PROCEDURE

Double layer tunnel flap preparation. Subperiosteally "sticky bone" containing platelet rich fibrin (PRF) and xenograft is utilized for bone augmentation, while supraperiosteally PRF membranes are used for soft tissue augmentation. Trough the vertical releasing incisions a piezosurgical device is used to perform corticotomy. 1 week after surgery OTM is initiated.

Test group

Bone augmentation without corticotomy PROCEDURE

Double layer tunnel flap preparation. Subperiosteally "sticky bone" containing platelet rich fibrin (PRF) and xenograft is utilized for bone augmentation, while supraperiosteally PRF membranes are used for soft tissue augmentation. Corticotomy is not performed in this group. 1 week after surgery OTM is initiated.

Control group

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• tooth crowding exceeding a 5mm lack of space (originating from the discrepancy between the overall mesiodostal length of the teeth and the length of the dental arch present at the time of the evaluation)
• thin bone morphotype (buccal width of the cortical layer must be under 1mm)
• incisor proclination in order to eliminate crowding without compensatory extractions.
• informed consent

You may not qualify if:

• ongoing periodontitis
• Pregnant women.
• Participation in another clinical study within 30 days prior to study start.
• Alcoholism, drug dependency, heavy smoking (\>5 cigarettes/day).
• Known infection with HIV, HBV, or HCV.
• Patients requiring chemo- or radiotherapy.
• Previous or current radiotherapy of the head.
• Uncontrolled or insulin-dependent diabetes mellitus
• Clinically relevant osteoporosis or systemic disease affecting bone metabolism
• Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months.
• Clinically relevant blood coagulation disorder.
• Previous or current treatment with systemic corticosteroids (within 2 months prior to screening visit) of more than 5 mg/day prednisone equivalent.
• Previous or current therapy with bisphosphonates at least for 30 days within the last 12 months before screening visit

Sponsors & Collaborators

• Semmelweis University: lead
• NSK Europe GmbH: collaborator

Study Sites (1)

Semmelweis University Department of Periodontology

Budapest, Budapest, 1088, Hungary

Location

Related Publications (6)

• Ahn HW, Seo DH, Kim SH, Park YG, Chung KR, Nelson G. Morphologic evaluation of dentoalveolar structures of mandibular anterior teeth during augmented corticotomy-assisted decompensation. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):659-669. doi: 10.1016/j.ajodo.2016.03.027.

  PMID: 27692424 BACKGROUND

• Artun J, Krogstad O. Periodontal status of mandibular incisors following excessive proclination. A study in adults with surgically treated mandibular prognathism. Am J Orthod Dentofacial Orthop. 1987 Mar;91(3):225-32. doi: 10.1016/0889-5406(87)90450-1.

  PMID: 3469907 BACKGROUND

• Coscia G, Coscia V, Peluso V, Addabbo F. Augmented corticotomy combined with accelerated orthodontic forces in class III orthognathic patients: morphologic aspects of the mandibular anterior ridge with cone-beam computed tomography. J Oral Maxillofac Surg. 2013 Oct;71(10):1760.e1-9. doi: 10.1016/j.joms.2013.04.022. Epub 2013 Jun 15.

  PMID: 23773424 BACKGROUND

• Lee KB, Lee DY, Ahn HW, Kim SH, Kim EC, Roitman I. Tooth movement out of the bony wall using augmented corticotomy with nonautogenous graft materials for bone regeneration. Biomed Res Int. 2014;2014:347508. doi: 10.1155/2014/347508. Epub 2014 Aug 27.

  PMID: 25247172 BACKGROUND

• Lund H, Grondahl K, Grondahl HG. Cone beam computed tomography evaluations of marginal alveolar bone before and after orthodontic treatment combined with premolar extractions. Eur J Oral Sci. 2012 Jun;120(3):201-11. doi: 10.1111/j.1600-0722.2012.00964.x.

  PMID: 22607336 BACKGROUND

• Murphy KG, Wilcko MT, Wilcko WM, Ferguson DJ. Periodontal accelerated osteogenic orthodontics: a description of the surgical technique. J Oral Maxillofac Surg. 2009 Oct;67(10):2160-6. doi: 10.1016/j.joms.2009.04.124. No abstract available.

  PMID: 19761909 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Peter Windisch, Professor

  Semmelweis University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The persons responsible to measure on the cephalogramms and CBCTs are blinded to the study design
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Subjects are randomly allocated either to test (bone augmentation with corticotomy) or control (without corticotomy) groups

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 3, 2022
• Study Start: April 1, 2019
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)