Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets

Tooth Loss Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00782236
• Other study ID #: CR 02/06
• Status: Terminated
• Phase: Phase 4
• First received: October 28, 2008
• Last updated: March 3, 2016
• Start date: June 2006
• Est. completion date: October 2009

Study information

• Verified date: March 2016
• Source: Institut Straumann AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Loss

Intervention

Device:
• Bone Graft Material
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of Straumann Bone Ceramic or Freeze Dried Allograft Bone (FDBA) with a resorbable collagen membrane (Bio-Gide) for preservation of the alveolar ridge following tooth extraction. Following 6 months of healing, a core of bone will be taken from the surgical site and a dental implant will be placed. The subjects will then be followed for 12 months following dental implant placement.

Locations

Country	Name	City	State
United States	Private Practice	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Institut Straumann AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Six weeks following dental implant placement	No
Secondary	Histological evaluation		6 months following tooth extraction	No
Secondary	Alveolar ridge width and height changes		6 months following tooth extraction	No
Secondary	Periodontal measurements		6 months following tooth extraction and 6 and 12 months following implant placement	No
Secondary	Grafting procedure success rate		14 days, 1 month, 3 months, and 6 months following tooth extraction	No
Secondary	Implant success and survival rate		6 weeks, 12 weeks, 6 months, and 12 months following implant placement	No
Secondary	Mesial and distal implant bone level changes		6 weeks, 12 weeks, 6 months, and 12 months following implant placement	No
Secondary	Patient satisfaction		6 and 12 months following implant placement	No