Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03837158

Titanium Zirconium (TiZr) Mini Implants

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Practice Dr. B. Wallkamm, Langenthal, Canton of Bern, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Early Loading

Procedure

two TiZr implants on SLA surface

Immediate loading

Procedure

four TiZr implants on SLA surface

Primary outcomes

  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 outcomes

  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

    • Gingival look inflamed, but don't bleed when probed
    • Gingival look inflamed and bleed when probed
    • 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

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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?

Important dates

Study start
2019
Primary completion
2024
Study completion
2033
First posted
Feb 12, 2019
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.