Buccal Plate Augmentation With Different Hydroxyapatite Based Material
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01344577|
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : February 23, 2017
|Condition or disease|
Tooth loss results physiologically in a significant remodeling of the alveolar ridge. The bone resorption process begins immediately after extraction, leading to an average 40-60% decrease in the horizontal and vertical dimensions of the alveolar ridge, during the first 2 years (Amler 1969, Johnson 1969)1,2. The majority of post-extraction bone loss is more evident on the buccal aspect of the ridge (Pietrokovski & Massler 1967)3 and occurs mainly within the first 3 months (Johnson 1969; Schropp et al. 2003)2,4. It is now known that crestal remodeling is strictly related to bundle bone resorption5 and that is more evident on the buccal plate where, especially in thin periodontal biotypes, can result in significant facial hard and soft tissue recessions. Bundle bone vascularization comes from periodontal ligament and it is interrupted by tooth extraction: for this reason bundle bone resorption and, consequent socket remodeling are impossible to prevent. Furthermore, modeling and remodeling of extraction sockets have a great variability in timing: a recent study (Trombelli et al. 2008) reports that bone organization and architecture is not completed 24 weeks after tooth extraction6.
In order to preserve ridge volumetry after extraction, many clinical techniques and various biomaterials have been suggested for grafting of post-extraction wounds7-12. Grafting of sockets provides stable clinical results but some studies demonstrate that, unless using a membrane, at histological examination most of the graft particles are encapsulated by fibrous tissue, especially in the coronal area 9,11. Recently, a study on an animal model (Araújo et al. 2009) reported that the presence of bone graft material in fresh extraction socket leads to a delayed healing response13.
On account of these observations, a novel surgical technique was presented in literature (Caiazzo et al. 2010)14, with the name of Buccal Plate Augmentation (BPA). After performing a gentle tooth extraction and verifying the integrity of the alveolar walls, BPA consists in placing a HA-based bone graft material over the intact buccal bone plate, underneath the soft tissues and the periosteum in a surgically created pouch with the aim to maintain or augment crestal volumetry and soft tissue aesthetics of the region. This approach allows for avoiding recession of the alveolar facial wall without interfering with the natural healing mechanism of the extraction socket, which is left undisturbed. To date, however, there is still no evidence regarding the most suitable biomaterial for maintaining predictably crestal volumetry and soft tissues contour overtime.
|Study Type :||Observational|
|Actual Enrollment :||96 participants|
|Official Title:||Buccal Plate Augmentation Associated With Different Hydroxyapatite-based Biomaterials. A Multicenter Randomized Controlled Clinical Trial|
|Actual Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
bone graft material used: Apatos Cortical® (porcine cortical bone 600-1000 µm)
bone graft material used: MP3® (porcine cortic-cancellous collagenated bone mix 600-1000 µm)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344577
|University of Trieste|
|Trieste, TS, Italy, 34100|
|Study Director:||Claudio Stacchi, DDS||University of Trieste|
|Principal Investigator:||Chiara O Navarra, DDS,PHD||University of Trieste|
|Study Chair:||Roberto Di Lenarda, DDS, PHD||University of Trieste|