Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

NCT00901017 | Completed Results

• 1 other identifier: CR 04/05
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.

Conditions

Jaw, Edentulous; Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

• Change of Vertical Height of Buccal Defects

  Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery

  Baseline to 26 weeks

Secondary Outcomes (4)

• Implant Success Rate

  6 months

• Implant Survival Rate

  6 Months

• Implant Success Rate

  12 months

• Implant Survival Rate

  12 months

Study Arms (2)

Straumann BoneCeramic

ACTIVE COMPARATOR

Straumann BoneCeramic

Device: Straumann BoneCeramic

Bio-Oss

ACTIVE COMPARATOR

Geistlich Bio-Oss

Device: Bio-Oss

Interventions

Straumann BoneCeramic DEVICE

Bone augmentation procedure performed with Bone Ceramic

Straumann BoneCeramic

Bio-Oss DEVICE

Bone Augmentation procedure performed with Bio Oss

Bio-Oss

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18 years to 80 years of age
• At least two missing teeth up to full edentulous arches.
• Desiring implant supported restorations.
• Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect).
• At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone.
• Sufficient bone volume such that both oral implants will not encroach on vital structures and primary stability of the oral implant can be achieved;
• Patients must be committed to the study and must sign informed consent.
• Patient in good general health as documented by self assessment;
• Full mouth plaque score of \<20%;

You may not qualify if:

• Any systemic medical condition that could interfere with the surgical procedure or planned treatment;
• Current pregnancy or breast feeding/ lactating at the time of recruitment;
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
• Alcoholism or chronically drug abuse causing systemic compromise.
• Patients who smoke more than 20 cigarettes per day.
• Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
• Lack of primary stability of 1 or both implant(s) at surgery, measured by hand testing. In this instance the patient must be withdrawn and treated accordingly.
• Mucosal diseases such as erosive lichen planus
• History of local radiation therapy.
• Presence of osseous pathologies.
• Presence of oral lesions (such as ulceration, malignancy)
• Severe bruxing or clenching habits.
• Local inflammation, including untreated periodontitis.
• Bone surgery at the implant site(s) (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement.
• Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease.

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Jaw, Edentulous; Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Marc Quirynen, Professor
• Organization: Institut Straumann AG

michael.hotze@straumann.com

+4161965

Study Officials

• Marc Quirynen, Professor

  KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• 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: March 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 30, 2016
• Results First Posted: November 5, 2012

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)