Clinical trial NCT03837158: Titanium Zirconium (TiZr) Mini Implants
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?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Geriatric Oral Health Assessment Index (GOHAI)
timeFrame: One-year follow-up
Secondary outcomes:
measure: Additional Oral Health Impact Profile for edentulism (OHIP-EDENT)
timeFrame: Follow-up (up to 365 days)
measure: Additional PROM Denture Satisfaction Index (DSI)
timeFrame: Baseline, follow-up (up to 365 days)
measure: Implant Survival
timeFrame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
measure: Implant Success
timeFrame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
measure: Prosthetic Survival
timeFrame: Baseline, follow-up (up to 365 days)
measure: Chewing Efficiency
timeFrame: Baseline, follow-up (up to 365 days)
measure: Plaque Index
timeFrame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
measure: Bleeding Index
timeFrame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
measure: Pocket Probing depth
timeFrame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
measure: Time-Cost-Analysis
timeFrame: After surgery, after implants loading, after follow-up (up to 365 days)
measure: Cost Effectiveness and Willingness to Pay
timeFrame: Total change and time at 1y follow-up
measure: In-vivo evaluated loss of retentive force
timeFrame: after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days)
Other outcomes:
Locations:
city: Langenthal
country: Switzerland
facility: Private Practice Dr. B. Wallkamm
state: Bern
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: Private Practice
name: Beat Wallkamm, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Martin Schimmel, Prof
role: STUDY_DIRECTOR
References: