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Trial record 87 of 119 for:    ZIRCONIUM

Titanium Zirconium (TiZr) Mini Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03837158
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
University of Bern

Brief Summary:
H0: "Within the first year post-placement, four interforaminally placed, immediately loaded 2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show improved patient-reported outcome measures (PROMS) compared to two interforaminally placed, early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular overdenture."The specific aim is to compare both treatment alternatives to evaluate which one may be recommended for elderly edentulous patients.

Condition or disease Intervention/treatment Phase
Dental Implants Procedure: early loading Procedure: immediate loading Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is the Stabilization of a Mandibular Overdenture Employing Four Novel One-piece Immediately Loaded TiZr Implants With Miniaturized Stud-type Attachments a Feasible Alternative to Two Two-piece Early Loaded Tissue-level Implants With Regular Stud-type Attachments?
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Control-group
Two Tissue Level TiZr Sand blasted long grit acid-etched (SLA) implants placed in positions 33 and 43 (diameter 3.3mm, length ≥10mm), early loading
Procedure: early loading
two TiZr implants on SLA surface

Experimental: Experimental-group
Four narrow-diameter implants (NDI) TiZr SLA implants in positions 34, 32, 42, and 44 (diameter 2.4mm, length ≥10mm), immediate loading
Procedure: immediate loading
four TiZr implants on SLA surface

Primary Outcome Measures :
  1. Geriatric Oral Health Assessment Index (GOHAI) [ Time Frame: One-year follow-up ]

    Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL).

    Scores 0-60: higher values represent lower OHRQoL

Secondary Outcome Measures :
  1. Additional Oral Health Impact Profile for edentulism (OHIP-EDENT) [ Time Frame: Follow-up (up to 365 days) ]
    Change from baseline questionnaires

  2. Additional PROM Denture Satisfaction Index (DSI) [ Time Frame: Baseline, follow-up (up to 365 days) ]
    Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm)

  3. Implant Survival [ Time Frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up ]
    Survival (yes/no)

  4. Implant Success [ Time Frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up ]
    Success according to Misch (2007) Misch criteria scores 1-4: higher values represent better success

  5. Prosthetic Survival [ Time Frame: Baseline, follow-up (up to 365 days) ]
    Prosthetic Survival (yes/no): is the denture still in place?

  6. Chewing Efficiency [ Time Frame: Baseline, follow-up (up to 365 days) ]
    Color mixing test

  7. Plaque Index [ Time Frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up ]

    Plaque Index Scores 0-3 3= thick plaque is visible along gingival margin 2= plaque is visible along gingival margin, with or without air drying

    1= following air drying, plaque is not visible but can be wiped off with an explorer 0= following air drying, plaque is not visible nor can be wiped off with an explorer

  8. Bleeding Index [ Time Frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up ]

    Bleeding Index Scores 0-3 0= Healthy gingival

    1. Gingival look inflamed, but don't bleed when probed
    2. Gingival look inflamed and bleed when probed
    3. Ulceration and spontaneous bleeding

  9. Pocket Probing depth [ Time Frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up ]
    depth measured in mm

  10. Time-Cost-Analysis [ Time Frame: After surgery, after implants loading, after follow-up (up to 365 days) ]
    Total treatment time will be collected and added. Total treatment cost will be evaluated and a ratio will be calculated. The groups will be compared on the base of this ration

  11. Cost Effectiveness and Willingness to Pay [ Time Frame: Total change and time at 1y follow-up ]
    Cost effectiveness wil be calculated as a ratio of treatment cost in relation to change of GOHAI sum score. This will allow to evaluate how much monetary item is needed to achieve a change in GOHAI

  12. In-vivo evaluated loss of retentive force [ Time Frame: after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days) ]
    Measurement with a hand-held digital force gauge

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • At patient level:

    • Written informed consent
    • Age ≥ 18 years
    • Sufficient complete dentures (Marxkors and Ferger, 1989) not older than 1 year
    • Patient is unsatisfied with mandibular denture to the degree that he/she seeks treatment
  • At site level:

    • Healed edentulous mandible (minimum 8 weeks since last extraction)
    • Minimal ridge dimensions 5.5 mm (width) by 12 mm (height) in the anterior (interforaminal) area, allowing the placement of 3.3 (endosseous diameter) by 10 mm (length) implants
    • Opposing dentition: complete denture on a edentulous maxilla
    • Physical status (PS) 1 and 2 (American Society of Anesthesiologists)

Exclusion Criteria:

  • At patient level

    • Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol
    • Any disorder that would interfere with wound healing or represent a contraindication for oral surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
    • Pregnancy or lactation
    • Heavy smoking habit with > 20 cig/d
    • Severe bruxism or clenching habits, present oro-facial pain
  • At site level:

    • Ridge defects requiring staged bone augmentation procedures (simultaneous Guided Bone Regeneration (GBR) within the ridge contour allowed)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03837158

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Contact: Martin Schimmel, Prof. 0316322597
Contact: Beatrice Gerber 0316328628

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Private Practice Not yet recruiting
Langenthal, Bern, Switzerland, 4900
Contact: Beat Wallkamm, Dr    062 919 40 10   
University of Bern Recruiting
Bern, Switzerland, 3010
Contact: Martin Schimmel, Prof.    +41316322597   
Sponsors and Collaborators
University of Bern
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Principal Investigator: Beat Wallkamm, Dr Private Practice
Study Director: Martin Schimmel, Prof University of Bern

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Responsible Party: University of Bern Identifier: NCT03837158     History of Changes
Other Study ID Numbers: Mini 1286_2018
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not planned to use the data of this study for future research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No