Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery

Dentsply Sirona Implants and Consumables23 enrolled

Overview

The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro). Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Jaw, Edentulous Poor Bone Quality

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 - 75 years of age * Bone quality class III or IV, (according to Lekholm \& Zarb16) * Willing to give signed informed consent Exclusion Criteria: * Need for bone augmentation of the maxilla * Tobacco smoking more than 5 cigarettes/day * Any systemic disease or condition that would compromise post-operative healing and/or osseointegration * Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * Unable or unwilling to return for follow-up visits * Bruxism or other parafunctional activity

Locations (3)

University of Iowa, College of Dentistry, Dow's Institute for Dental Research

Iowa City, Iowa, United States

Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken

Gävle, Sweden

Odontologiska kliniken, Länssjukhuset

Halmstad, Sweden