Titanium Zirconium (TiZr) Mini Implants

Not Applicable

Active, not recruiting

• Conditions: Dental Implants
• Interventions: Procedure: immediate loading; Procedure: early loading

• Registration Number: NCT03837158
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-12
• Study Start: 2019-09-01
• Primary Completion: 2024-09-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Study Completion: 2033-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental-group	immediate loading	Four narrow-diameter implants (NDI) TiZr SLA implants in positions 34, 32, 42, and 44 (diameter 2.4mm, length ≥10mm), immediate loading
Control-group	early loading	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

Primary Outcome Measures

Name	Time	Method
Geriatric Oral Health Assessment Index (GOHAI)	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

Name	Time	Method
Additional PROM Denture Satisfaction Index (DSI)	Baseline, follow-up (up to 365 days)	Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm)
Implant Survival	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)
Additional Oral Health Impact Profile for edentulism (OHIP-EDENT)	Follow-up (up to 365 days)	Change from baseline questionnaires
Implant Success	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
Plaque Index	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
Bleeding Index	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
Pocket Probing depth	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
In-vivo evaluated loss of retentive force	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
Time-Cost-Analysis	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
Chewing Efficiency	Baseline, follow-up (up to 365 days)	Color mixing test
Cost Effectiveness and Willingness to Pay	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
Prosthetic Survival	Baseline, follow-up (up to 365 days)	Prosthetic Survival (yes/no): is the denture still in place?

Trial Locations

Locations (2)

Private Practice Dr. B. Wallkamm; 🇨🇭 Langenthal, Bern, Switzerland

University of Bern; 🇨🇭 Bern, Switzerland