The Introduction of a Novel PAOO Technique

A Novel Periodontally Accelerated Osteogenic Orthodontics (PAOO) in the Prevention of Buccal Bone Dehiscence in Patients Receiving Orthodontic Therapy- a Randomized Controlled Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Bone Loss; Tooth Movement
• Intervention / Treatment: Procedure: Bone augmentation with minimally invasive corticotomy (piezotomy); Procedure: Bone augmentation without corticotomy

Detailed Description

Patients presenting teeth crowding in mandibulary or maxillary front area, without ongoing periodontal disease, who require OTM with incisor proclination, are included in the study. Patients are randomly allocated into test and control groups. Individuals in both groups receive before OTM a buccal bone augmentation in order to further increase the bony envelope where to teeth are intended to move. Test subjects receive a selected decorticalistation of the buccal bone with a piezosurgical device (piezotomy), while control patients are augmented without piezotomy. 1 week postsurgical multibond orthodontic appliances are bonded to initiate OTM. Teeth movement are measured on cephalometric X-ray images, where an initial and a final (at the end of the nivellation phase) cephalogramm is compared with each other. Buccal bone dimensions are measured on initial and 6th month's postoperatively CBCT images. The investigators' hypothesis is that the buccal bone thickness can be significantly increased, which might prevent the development of gingival recessions. This means, that in both groups the initial and final bone volumes will be comparable without significant difference. It is also hypothesized that the bone changes will not differ significantly between the two groups. However, piezotomy in the test group might have an additional benefit throughout regional acceleratory phenomenon, reducing the duration of OTM.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest
    • Budapest, Budapest, Hungary, 1088
      • Semmelweis University Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Test patients receive bone augmentation and selective decorticalisation (corticotomy) and 1 week postop. OTM.	Procedure: Bone augmentation with minimally invasive corticotomy (piezotomy); 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.
Active Comparator: Control group; Control subjects receive bone augmentation without decorticalisation (corticotomy) and 1 week postop. OTM.	Procedure: Bone augmentation without corticotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical bone level	The distance between the cement-enamel junction and the crestal bone on the buccal aspect of the mandibular anterior teeth.	6 months postoperatively
Horizontal bone levels	The buccal bone thickness measured at 4,7 and 9mm distances from the cement-enamel junction of the mandibular anterior teeth. The thickness is measured on CBCT coronal slices.	6 months postoperatively

Collaborators and Investigators

• Sponsor: Semmelweis University
• Collaborators: NSK Europe GmbH
• Investigators: Study Director: Peter Windisch, Professor, Semmelweis University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: bone augmentation; orthodontic tooth movement; corticotomy; periodontally accelerated osteogenic orthodontics
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: PIEZO-ORTHO

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