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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Controlled, Double Blind, Clinical Trial to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Ø Bone Level Implants by Comparing Two Dif

Brief Summary: 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.

Detailed Summary:

This is a clinical trial to compare crestal bone level changes, soft tissue parameters, implant success and survival between small diameter implants in edentulous mandibles restored with removable overdentures.

An initial patient evaluation will be conducted to determine wether a patient meets the study inclusion and exclusion criteria.

The edentulous subjects will undergo surgery for placement of two dental implants, the test and control implant. The implants will be placed in the intraforaminal region.

A gingival former will be inserted in the implant after implant placement to ensures a transmucosal healing. After 6 to 8 weeks the healing abutments will be retrieved and the locator abutments will be connected to the implant.

The removable prosthesis will be prepared and connected to the implants two weeks later.

The study will be blinded until 12 month post surgery and completed with an unblinded follow up period up to 3 years.

Straumann will deliver the randomization envelopes to the sites which had been created by an independent Clinical Research Organization (CRO). The randomization envelopes are marked with a sequential number. The master randomization list will be kept at Straumann.

The success and survival of the implants, soft tissue conditions, success of the prosthesis part and product safety will be assessed after 6, 12, 24, and 36 month after surgery.

Source data verification will be performed by qualified study monitors to assess the accuracy, completeness, or representativeness of registry data by comparing the d
Sponsor: Institut Straumann AG

Current Primary Outcome: 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 ]

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.



Original Primary Outcome: Change in Crestal Bone Level between surgery and 12 months [ Time Frame: 12 months ]

Current Secondary Outcome:

  • 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 ]

    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 ]

    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.



Original Secondary Outcome: Success and Survival Rate of the Study Implants [ Time Frame: at 6,12, 24 and 36 post loading ]

Information By: Institut Straumann AG

Dates:
Date Received: May 20, 2009
Date Started: November 2007
Date Completion:
Last Updated: March 2, 2016
Last Verified: March 2016