Comparison of Straumann Bone Ceramic and Bio-Oss With Guided Tissue Regeneration for Alveolar Ridge Preservation

NCT00900718 | Completed

• 1 other identifier: CR 03/05
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (1)

• The changes of bone level between baseline and 32 week post-extraction

  baseline and 32 week post-extraction

Secondary Outcomes (1)

• implant success and survival rate

  1 year post implant loading

Study Arms (2)

Straumann Bone Ceramic

EXPERIMENTAL

Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.

Device: Straumann Bone Ceramic

Bio-Oss

ACTIVE COMPARATOR

Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.

Device: Bio-Oss

Interventions

Straumann Bone Ceramic DEVICE

Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.

Also known as: Synthetic Bone Substitute

Straumann Bone Ceramic

Bio-Oss DEVICE

Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.

Also known as: Xenograft

Bio-Oss

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

Eastman Dental Institute, University College London

London, WC1X8LD, United Kingdom

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Nikolaos Donos, DDS, MS, PhD

  Eastman Dental Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: February 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 3, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)