Buccal Plate Augmentation With Different Hydroxyapatite Based Material

NCT01344577 | Completed DMC

• 1 other identifier: BPA-2011-units
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulous

Keywords

Buccal Plate Augmentation technique; socket preservation; porcine biomaterial

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Trieste: lead
• University of Ljubljana School of Medicine, Slovenia: collaborator

Study Sites (1)

University of Trieste

Trieste, TS, 34100, Italy

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Claudio Stacchi, DDS

  University of Trieste

  STUDY DIRECTOR

• Chiara O Navarra, DDS,PHD

  University of Trieste

  PRINCIPAL INVESTIGATOR

• Roberto Di Lenarda, DDS, PHD

  University of Trieste

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 29, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

IT (1)