Titanium Zirconium (TiZr) Mini Implants

NCT ID: NCT03837158

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2033-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

early loading

Intervention Type: PROCEDURE

two TiZr implants on SLA surface

Experimental-group

Four narrow-diameter implants (NDI) TiZr SLA implants in positions 34, 32, 42, and 44 (diameter 2.4mm, length ≥10mm), immediate loading

Group Type: EXPERIMENTAL

immediate loading

Intervention Type: PROCEDURE

four TiZr implants on SLA surface

Interventions

early loading

two TiZr implants on SLA surface

Intervention Type: PROCEDURE

immediate loading

four TiZr implants on SLA surface

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beat Wallkamm, Dr

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Martin Schimmel, Prof

Role: STUDY_DIRECTOR

University of Bern

Locations

Private Practice Dr. B. Wallkamm

Langenthal, Canton of Bern, Switzerland

University of Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

Mini 1286_2018

Identifier Type: -

Identifier Source: org_study_id