Bone LossNCT05264480
The Introduction of a Novel PAOO Technique
A study testing Bone augmentation with minimally invasive corticotomy (piezotomy) and Bone augmentation without corticotomy in people with Bone Loss and Tooth Movement, run by Semmelweis University at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Tooth Movement
- What is being tested?
- Bone augmentation with minimally invasive corticotomy (piezotomy) and Bone augmentation without corticotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 1 Apr 2019to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University Department of Periodontology
Budapest, Budapest, 1088
About this study
Official title: 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).
Read the 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.
- Conditions
- Bone Loss, Tooth Movement
- Being tested
- Bone augmentation with minimally invasive corticotomy (piezotomy), Bone augmentation without corticotomy
- Keywords
- periodontally accelerated osteogenic orthodontics, orthodontic tooth movement, corticotomy, bone augmentation
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone augmentation with minimally invasive corticotomy (piezotomy)Procedure or surgery
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.
Bone augmentation without corticotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Test patients receive bone augmentation and selective decorticalisation (corticotomy) and 1 week postop. OTM. Receives: 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. Receives: Procedure: Bone augmentation without corticotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The distance between the cement-enamel junction and the crestal bone on the buccal aspect of the mandibular anterior teeth.
Measured: 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.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Apr 2019
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are randomly allocated either to test (bone augmentation with corticotomy) or control (without corticotomy) groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- NSK Europe GmbH
- Responsible party
- Principal investigator, Pal Nagy, Semmelweis University
- Investigators
- Peter Windisch, Professor, Study director, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264480
- Sponsor's protocol ID
- PIEZO-ORTHO
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27692424Artun 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.
PubMed 3469907Coscia 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.
PubMed 23773424Lee 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.
PubMed 25247172Lund 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.
PubMed 22607336Murphy 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.
PubMed 19761909
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Periodontally Accelerated Osteogenic Orthodontics (PAOO) in the Prevention of Buccal Bone Dehiscence in Patients Receiving Orthodontic Therapy- a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05264480
- Acronym / sponsor ID
- PIEZO-ORTHO
- Conditions
- Bone Loss, Tooth Movement
- Keywords
- periodontally accelerated osteogenic orthodontics, orthodontic tooth movement, corticotomy, bone augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- NSK Europe GmbH
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects are randomly allocated either to test (bone augmentation with corticotomy) or control (without corticotomy) groups
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Bone augmentation with minimally invasive corticotomy (piezotomy)Test patients receive bone augmentation and selective decorticalisation (corticotomy) and 1 week postop. OTM. |
| Control group | Active comparator | Procedure: Bone augmentation without corticotomyControl subjects receive bone augmentation without decorticalisation (corticotomy) and 1 week postop. OTM. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Test group |
| Bone augmentation without corticotomyDouble 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. | Procedure or surgery | Control group |
Primary outcome
Speed of OTM
Time frame: 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.
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.
2 secondary outcomes
Vertical bone level
Time frame: 6 months postoperatively
Horizontal bone levels
Time frame: 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 27692424Ahn 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.
- Background: PubMed 3469907Artun 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.
- Background: PubMed 23773424Coscia 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.
- Background: PubMed 25247172Lee 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.
- Background: PubMed 22607336Lund 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.
- Background: PubMed 19761909Murphy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Windisch, Professor study director
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone augmentation with minimally invasive corticotomy (piezotomy) and Bone augmentation without corticotomy in people with Bone Loss and Tooth Movement, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of OTM (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05264480, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.