The Introduction of a Novel PAOO Technique

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Loss, Tooth Movement

Intervention / Treatment
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* Procedure: Bone augmentation with minimally invasive corticotomy (piezotomy)
* Procedure: Bone augmentation without corticotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects are randomly allocated either to test (bone augmentation with corticotomy) or control (without corticotomy) groups
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontally accelerated osteogenic orthodontics, orthodontic tooth movement, corticotomy, bone augmentation