Titanium Zirconium (TiZr) Mini Implants

NCT03837158 | Active Not Recruiting

• 1 other identifier: Mini 1286_2018
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• Geriatric Oral Health Assessment Index (GOHAI)

  Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL). Scores 0-60: higher values represent lower OHRQoL

  One-year follow-up

Secondary Outcomes (12)

• Additional Oral Health Impact Profile for edentulism (OHIP-EDENT)

  Follow-up (up to 365 days)

• Additional PROM Denture Satisfaction Index (DSI)

  Baseline, follow-up (up to 365 days)

• Implant Survival

  at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up

• Implant Success

  at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up

• Prosthetic Survival

  Baseline, follow-up (up to 365 days)

Study Arms (2)

Control-group

EXPERIMENTAL

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

Experimental-group

EXPERIMENTAL

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

Interventions

early loading PROCEDURE

two TiZr implants on SLA surface

Control-group

immediate loading PROCEDURE

four TiZr implants on SLA surface

Experimental-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bern: lead

Study Sites (2)

Private Practice Dr. B. Wallkamm

Langenthal, Canton of Bern, 4900, Switzerland

Location

University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Beat Wallkamm, Dr

  Private Practice

  PRINCIPAL INVESTIGATOR

• Martin Schimmel, Prof

  University of Bern

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 12, 2019
• Study Start: September 1, 2019
• Primary Completion: September 10, 2024
• Study Completion (Estimated): August 1, 2033
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)