Clinical trial NCT00900718: Comparison of Straumann Bone Ceramic and Bio-Oss With Guided Tissue Regeneration for Alveolar Ridge Preservation
Official title: Comparison of Straumann Bone Ceramic (SBC) and Bio-Oss in Combination With Guided Tissue Regeneration (GTR) for Volume Preservation of Alveolar Ridge After Tooth Extraction: a Randomised, Single Blind, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a new biomaterial with an already existing treatment principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the alveolar ridge and to promote bone regeneration and to evaluate the early survival rate of dental implants placed in the augmented socket area and to assess radiographically and clinically changes of peri-implant soft and hard tissues.

Detailed description: This is prospective, randomized, single-blind, controlled, single center study. The total study duration for each patient should be 12 +/- 1 month.

In total 13 visits per patient are scheduled in this study.

The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication.

One center in the Inited Kingdom will participate.

Eligibility criteria: Inclusion Criteria:

* Patient must have voluntarily signed the informed consent
* Males and females, 18 years to 75 years of age
* Patient needs single tooth extraction in mandibular or maxillary incisor or pre-molar region and would benefit from prosthetic reconstruction with a dental implant
* Patients must be committed to the study and must sign informed consent
* Patient in good general health as documented by self assessment

Exclusion Criteria:

Systemic exclusion criteria

* Patient who has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation
* Female patient who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence
* Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit
* Patient who are on concomitant anticoagulant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily asprin of more than 81 mg.
* Patient who knowingly has HIV or Hepatitis
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* Patient who has undergone administration of any investigational drug within 30 days of study initiation.
* Alcoholism or chronically drug abuse causing systemic compromisation
* Patient who is a heavy smoker (\>10/cigarettes per day).
* Patient is suffering from a known psychological disorder
* Patient has limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed

Local exclusion criteria

* Uncontrolled or untreated periodontal disease
* Bone defects that excludes implant restoration
* Patient who has a full mouth plaque level \>30 % at the enrolment visit
* Mucosal diseases such as erosive lichen planus
* History of local radiation therapy
* Presence of oral lesions (such as ulceration, malignancy)
* Severe bruxing or clenching habits
* Persistent intraoral infection
* Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
* Patient presents an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible)

Primary outcomes:
measure: The changes of bone level between baseline and 32 week post-extraction
timeFrame: baseline and 32 week post-extraction
Secondary outcomes:
measure: implant success and survival rate
timeFrame: 1 year post implant loading
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Eastman Dental Institute, University College London
Study officials:
affiliation: Eastman Dental Institute
name: Nikolaos Donos, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: