A Study to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00905840
First received: May 20, 2009
Last updated: January 14, 2015
Last verified: January 2015
  Purpose

The purpose of this study is to assess the change of crestal bone level at the Titanium Zirconium (TiZr) compared to Titanium (grade IV) implant between surgery and 6, 12, 24, and 36 month post surgery.


Condition Intervention
Jaw, Edentulous
Device: Titanium Zircon implant
Device: Titanium Grade IV implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double Blind, Clinical Trial to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Ø Bone Level Implants Which Will be Restored With a Removable Prosthesis by Comparing Two Different Implant Alloys in Split Mouth Design

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material.

    The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used.



Secondary Outcome Measures:
  • Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990 [ Time Frame: at 12, 24 and 36 months post surgery ] [ Designated as safety issue: No ]

    split-mouth design

    Implant success and survival rate according the definition by Buser et al. 1990 are:

    • Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysaesthesia
    • Absence of a recurrent peri-implant infection with suppuration
    • Absence of mobility
    • Absence of a continuous radiolucency around the implant
    • Possibility for restoration

  • Soft Tissue and Safety Assessments [ Time Frame: after 12, 24, and 36 month ] [ Designated as safety issue: Yes ]

    Modified Plaque Index (mPI) and modified Sulcus Bleeding Index (mSBI) according to Mombelli at al. (1987). Assessment to be perform at four sites per implant: lingual, buccal, mesial, and distal.

    mPI: 0=no plaque detected, 1=plaque only recognized by running a probe across the smooth marginal surface of the implant, 2=plaque can be seen by the naked eye, 3=abundance of soft matter.

    mSBI: 0=no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant, 1=isolated bleeding spot visible, 2=blood forms a confluent red line on margin, 3=heavy or profuse bleeding.

    Safety evaluations including recording of all complications, adverse events (AEs), and serious adverse events SAEs). Each AE and SAE will be assessed for severity and its potential relationship to the study device.



Enrollment: 91
Study Start Date: November 2007
Study Completion Date: September 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Titanium Zircon implant
Intervention: each subject will receive two Straumann bone level implants, one implant is fabricated with Titanium Zircon and the other is a grade IV Titanium implant. Both implants will be randomly placed in the interforaminal region of the edentulous mandible, one on the right half and the other in the left part. Both implants will be treated the same way.
Device: Titanium Grade IV implant

The implant surgery is performed under local anesthesia following standard surgical techniques. The surgeon will be supported by one or two assistants.

The bone will be excavated and prepared for the placement of the implant. After the implant was placed by using a hand ratched or motor drive device, a healing abutment will be inserted to ensure a transmucosal healing.

Placebo Comparator: Titanium Grade IV implant
Intervention: each subject will receive two Straumann bone level implants, one implant is fabricated with Titanium Zircon and the other is a grade IV Titanium implant. Both implants will be randomly placed in the interforaminal region of the edentulous mandible, one on the right half and the other in the left part. Both implants will be treated the same way.
Device: Titanium Zircon implant

The implant surgery is performed under local anesthesia following standard surgical techniques. The surgeon will be supported by one or two assistants.

The bone will be excavated and prepared for the placement of the implant. After the implant was placed by using a hand ratched or motor drive device, a healing abutment will be inserted to ensure a transmucosal healing.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must have voluntarily signed the informed consent form
  • Males and females must be 18 years of age.
  • Patients must present with an edentulous mandible at the time of surgery.
  • The last tooth or teeth in the mandible must have been extracted or lost more than 8 weeks before the date of first stage surgery.
  • The opposing dentition must be edentulous with a denture (implant borne or conventional) or natural or restored teeth
  • Adequate bone height of at least 9 mm above vital structures (because the minimal available implant lengths is 8mm) in the intraforaminal region. Available bone width should be in such way that 3.3 mm implants can be placed without the use of concurrent bone augmentation techniques. Harvested bone from the drilling sites may be used to cover minor dehiscence defects.
  • Patients must be committed to participate in the study for three years of follow-up examinations

Exclusion Criteria:

  • Medical conditions requiring prolonged use of steroids
  • History of leukocyte dysfunction and deficiencies
  • Patients with sever hemophilia
  • History of head and neck radiation or chemotherapy
  • Patients with history of renal failure
  • The application of bisphosphonate medication
  • History of uncontrolled endocrine disorders
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day 0.
  • Alcoholism or drug abuse
  • Patients with known infection of HIV
  • Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco (not greater than 10 cigarette equivalents)
  • Fertile females with no adequate method of birth control (contraceptive pill, barrier method, etc.)
  • 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, unreliability.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905840

Locations
Belgium
Catholic University Leuven School of Dentistry
Leuven, Belgium, 3000
Germany
J. Gutenberg University, Oral and Maxillofacial Surgery
Mainz, Germany, 55131
Klinikum der Universität Regensburg
Regensburg, Germany, 93053
Italy
Universitá degli Studi di Milano
Milano, Italy, 20142
Netherlands
Academic Center for Dentistry Amsterdam (ACTA)
Amsterdam, Netherlands, 1066 EA
University Medical Center Groningen- UMCG
Groningen, Netherlands
Switzerland
Université de Genève- Section médicine dentaire
Geneve, Switzerland, 1211
Kantonsspital Luzern
Luzern, Switzerland, 6000
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Bilal Al-Nawas, PD Dr. J. Gutenberg University
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00905840     History of Changes
Other Study ID Numbers: CR 04/07
Study First Received: May 20, 2009
Results First Received: August 14, 2014
Last Updated: January 14, 2015
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
Belgium: Institutional Review Board
Netherlands: Independent Ethics Committee
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Jaw, Edentulous
Mouth, Edentulous
Jaw Diseases
Mouth Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on May 29, 2015