Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets - Full Text View

Purpose

The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).

Condition	Intervention	Phase
Tooth Loss	Device: Bone Graft Material	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of an Alloplast (Straumann Bone Ceramic) to an Allograft of Freeze Dried Bone (FDBA) for Preservation of the Alveolar Ridge Following Tooth Extraction: a Prospective, Randomized, Controlled Clinical Study

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:

Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved. [ Time Frame: Six weeks following dental implant placement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Histological evaluation [ Time Frame: 6 months following tooth extraction ] [ Designated as safety issue: No ]
Alveolar ridge width and height changes [ Time Frame: 6 months following tooth extraction ] [ Designated as safety issue: No ]
Periodontal measurements [ Time Frame: 6 months following tooth extraction and 6 and 12 months following implant placement ] [ Designated as safety issue: No ]
Grafting procedure success rate [ Time Frame: 14 days, 1 month, 3 months, and 6 months following tooth extraction ] [ Designated as safety issue: No ]
Implant success and survival rate [ Time Frame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement ] [ Designated as safety issue: No ]
Mesial and distal implant bone level changes [ Time Frame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement ] [ Designated as safety issue: No ]
Patient satisfaction [ Time Frame: 6 and 12 months following implant placement ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	June 2006
Study Completion Date:	October 2009
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Straumann BoneCeramic	Device: Bone Graft Material Straumann BoneCeramic versus Freeze Dried Allograft Bone Other Names: Synthetic bone substitute Allograft bone
Active Comparator: Freeze Dried Allograft Bone	Device: Bone Graft Material Straumann BoneCeramic versus Freeze Dried Allograft Bone Other Names: Synthetic bone substitute Allograft bone

Detailed Description:

Subjects will undergo a single tooth extraction and then will be randomized to receive SBC or FDBA. Following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. The subject will be followed for one year following dental implant placement for implant success and survival.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must have voluntarily signed the informed consent form
Subjects must be between the ages of 18 and 80
Subjects must need a single tooth extraction in ADA sites 3-6 and 11-14 without septal bone in the maxilla and in ADA sites 19-30 without septal bone in the mandible and would benefit from prosthetic reconstruction with a dental implant
Subjects must be committed to the study and the required follow-up visits
Subjects must be in good general health as assessed by the Investigator

Exclusion Criteria:

Presence of conditions requiring chronic routine prophylactic use of antibiotics
Pregnancy
Medical conditions requiring prolonged use of steroids
History of leukocyte dysfunction and deficiencies
History of bleeding disorders
History of neoplastic disease requiring the use of chemotherapy
History of radiation therapy to the head and neck
Subjects with a history of renal failure
Subjects with severe or uncontrolled metabolic bone disorders
Uncontrolled endocrine disorders
Subjects who knowingly have HIV or hepatitis
Physical handicaps that would interfere with the ability to perform adequate oral hygiene
Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study
Alcoholism or drug abuse
Subjects who are heavy smokers (>10 cigarettes per day or cigar equivalents) or chew tobacco
Conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
Local inflammation including untreated periodontitis
Mucosal diseases such as erosive lichen planus
History of local radiation therapy
Presence of oral lesions (such as ulcerations or malignancy)
Bone defects that exclude implant restoration
Subjects who have a full mouth plaque level >30% at the baseline visit
Severe bruxing or clenching habits
Persistent intra-oral infection
Subjects presenting with an acute abscess in the tooth to be extracted or in the adjacent teeth to the extraction site (sites with presence of asymptomatic chronic lesions are eligible)
Subjects with inadequate oral hygiene or unmotivated for adequate home care
At the time of tooth extraction, if any bony wall is severely damaged or completely lost (i.e., anything other than a four wall extraction socket)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782236

Locations

United States, Pennsylvania
Private Practice
Yardley, Pennsylvania, United States, 19067

Sponsors and Collaborators

Institut Straumann AG

Investigators

Principal Investigator:

Paul S. Rosen, DMD, MS

Private Practice

More Information

No publications provided

Responsible Party:	Institut Straumann AG
ClinicalTrials.gov Identifier:	NCT00782236 History of Changes
Other Study ID Numbers:	CR 02/06
Study First Received:	October 28, 2008
Last Updated:	June 6, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on May 16, 2013