Titanium Zirconium (TiZr) Mini Implants

University of Bern

Status: Active, not recruiting

Conditions: Dental Implants

Treatments: Procedure: immediate loading; Procedure: early loading

Study type: Interventional

Funder types: Other

Identifiers

NCT03837158

Mini 1286_2018

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Control-group

Experimental group

Description:

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

Treatment:

Procedure: early loading

Experimental-group

Experimental group

Description:

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

Treatment:

Procedure: immediate loading