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Titanium Zirconium (TiZr) Mini Implants

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ClinicalTrials.gov Identifier: NCT03837158
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : July 9, 2019
Sponsor:
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?
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03837158


Contacts
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Contact: Martin Schimmel, Prof. 0316322597 martin.schimmel@zmk.unibe.ch
Contact: Beatrice Gerber 0316328628 beatrice.gerber@zmk.unibe.ch

Locations
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Switzerland
Private Practice Not yet recruiting
Langenthal, Bern, Switzerland, 4900
Contact: Beat Wallkamm, Dr    062 919 40 10    wallkamm@bluewin.ch   
University of Bern Not yet recruiting
Bern, Switzerland, 3010
Contact: Martin Schimmel, Prof.    +41316322597    martin.schimmel@zmk.unibe.ch   
Sponsors and Collaborators
University of Bern
Investigators
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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
ClinicalTrials.gov Identifier: NCT03837158     History of Changes
Other Study ID Numbers: Mini 1286_2018
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 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