Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets

Stopped early · Phase 4

Conditions studied: Tooth Loss

In brief

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).

Key facts

Study ID

NCT00782236

Run by

Institut Straumann AG

People needed

13

Starts

2006-06-01

Expected to finish

2009-10-01

Last updated by the study team

2016-03-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Private Practice — Yardley, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.