Bone Loss, Tooth Movement
Conditions
Keywords
periodontally accelerated osteogenic orthodontics, orthodontic tooth movement, corticotomy, bone augmentation
Brief 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.
Interventions
PROCEDUREBone 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.
PROCEDUREBone 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.
Sponsors
Semmelweis University
NSK Europe GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The persons responsible to measure on the cephalogramms and CBCTs are blinded to the study design
Intervention model description
Subjects are randomly allocated either to test (bone augmentation with corticotomy) or control (without corticotomy) groups
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vertical bone level | 6 months postoperatively | The distance between the cement-enamel junction and the crestal bone on the buccal aspect of the mandibular anterior teeth. |
| Horizontal bone levels | 6 months postoperatively | 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. |
Countries
Hungary
Contacts
STUDY_DIRECTORPeter Windisch, Professor
Semmelweis University
Outcome results
None listed