NCT05264480

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2022-03-03
• Last updated: 2025-01-08

Locations

1 site across 1 country: Hungary