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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Loss
• Intervention / Treatment: Device: Straumann Bone Ceramic; Device: Bio-Oss

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1X8LD
    • Eastman Dental Institute, University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Straumann Bone Ceramic; 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; Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.; Other Names: Synthetic Bone Substitute
ACTIVE_COMPARATOR: Bio-Oss; Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.	Device: Bio-Oss; Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.; Other Names: Xenograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The changes of bone level between baseline and 32 week post-extraction	baseline and 32 week post-extraction

Secondary Outcome Measures

Outcome Measure	Time Frame
implant success and survival rate	1 year post implant loading

Collaborators and Investigators

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: Nikolaos Donos, DDS, MS, PhD, Eastman Dental Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (ACTUAL): April 1, 2008
• Study Completion (ACTUAL): April 1, 2008

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (ESTIMATE): May 13, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CR 03/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO