Buccal Plate Augmentation With Different Hydroxyapatite Based Material

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Trieste.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
chiara navarra, University of Trieste
ClinicalTrials.gov Identifier:
NCT01344577
First received: April 27, 2011
Last updated: September 16, 2012
Last verified: September 2012
  Purpose

The purposes of this study are : (first) to evaluate comparatively the effectiveness of 2 HA-based biomaterials when used for socket preservation with Buccal Plate Augmentation technique; (second) to evaluate clinical outcomes of socket preservation procedures performed using the Buccal Plate Augmentation technique.


Condition Phase
Edentulous
Phase 0

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Buccal Plate Augmentation Associated With Different Hydroxyapatite-based Biomaterials. A Multicenter Randomized Controlled Clinical Trial

Further study details as provided by University of Trieste:

Estimated Enrollment: 96
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group1#
bone graft material used: Apatos Cortical® (porcine cortical bone 600-1000 µm)
Group2#
bone graft material used: MP3® (porcine cortic-cancellous collagenated bone mix 600-1000 µm)
Group3#
control group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • The local inclusion criteria are the following:

    1. indication for a tooth extraction in the incisor, canine or premolar area of the upper arch (for any clinical reason);
    2. presence of at least one tooth adjacent to the one to be extracted;
    3. presence of at least 5 mm. of vertical bone support around the tooth to be extracted;
    4. presence of an intact buccal plate in the extraction socket;
    5. age of the patient >18 years;
    6. patient will not wear any kind of removable prosthesis over the treatment area;
    7. patient will not undergo implant surgery in the treatment area up to 6 month from the extraction;
    8. patient willing and fully capable to comply with the study protocol;
    9. written informed consent given

Exclusion Criteria:

  • acute myocardial infarction within the past 2 months,
  • uncontrolled coagulation disorders,
  • uncontrolled metabolic diseases (diabetes mellitus and bone pathologies),
  • radiotherapy to the head/neck district within the past 24 months,
  • present or past treatment with intravenous bisphosphonates,
  • psychological or psychiatric problems, and alcohol or drugs abuse.
  • Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344577

Contacts
Contact: Roberto Di Lenarda, DDS, PHD 0039 040 3992168 r.dilenarda@fmc.units.it

Locations
Italy
University of Trieste Recruiting
Trieste, TS, Italy, 34100
Contact: Roberto di lenarda, DDS,PHD         
Sponsors and Collaborators
University of Trieste
University of Ljubljana School of Medicine, Slovenia
Investigators
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
  More Information

No publications provided

Responsible Party: chiara navarra, doctor, University of Trieste
ClinicalTrials.gov Identifier: NCT01344577     History of Changes
Other Study ID Numbers: BPA-2011-units
Study First Received: April 27, 2011
Last Updated: September 16, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Trieste:
Buccal Plate Augmentation technique
socket preservation
porcine biomaterial

ClinicalTrials.gov processed this record on September 30, 2014