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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05264480
Other study ID # PIEZO-ORTHO
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date November 1, 2024

Study information

Verified date November 2023
Source Semmelweis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 orthodontic tooth movement (OTM).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Hungary Semmelweis University Department of Periodontology Budapest

Sponsors (2)

Lead Sponsor Collaborator
Semmelweis University NSK Europe GmbH

Country where clinical trial is conducted

Hungary, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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