Clinical trial NCT02374216: A Prospective Analysis of Failures of Oral Implants
Official title: A Prospective Analysis of Failures/Complications With Oral Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failure
Periodontal Bone Loss
Keywords: Dental Implants
Periodontal Bone Loss
Implant-Supported Dental Prosthesis
Dental Prosthesis Failure
Lead sponsor: Malmö University
Sponsor class: OTHER
Collaborators: name: Region Skane
First posted: 2015-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this prospective clinical trial is to investigate and identify factors associated with the failure of dental implants within the population rehabilitated with dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).

Detailed description: The treatment begins with screening against inclusion and exclusion criteria. The patients will then be informed of the design of the study through the reading of the Form for Patient Information and the Informed Consent in Swedish and verbally.

All dental implants to be inserted will be included in the study. Some surgical, implant, loading, prosthetic variables of the study will be decided according to the surgeon's criteria and patient's decisions.

Data will be collected in specific forms, and will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and complications.

Besides descriptive statistics, Kaplan-Meier analysis will be used to estimate implant survival/failure rates (an estimator for estimating the survival function from lifetime data), and multivariate Cox proportional hazards models will be used to identify prognostic variables.

Eligibility criteria: Inclusion Criteria:

* Patients with a minimum age of 18 years;
* Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.

Exclusion Criteria:

* Age less than 18 years;
* General contraindications for implant surgery;
* Subjects with an untreated systemic disease. A complete medical report will permit the disqualification of subjects with an untreated systemic disease. Patients with a systemic disease such as diabetes or hypertension will not be excluded, as long as these pathologies were treated and stabilized within normal biologic parameters.

Primary outcomes:
measure: Survival of implants
timeFrame: Up to 3 years
Secondary outcomes:
measure: Marginal bone loss
timeFrame: Up to 3 years
measure: Dental prosthesis complications
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Folktandvården Specialistklinik
state: Skåne
Study officials:
affiliation: Malmö University
name: Bruno R Chrcanovic, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Malmö University
name: Ann Wennerberg, DDS PhD
role: STUDY_CHAIR
affiliation: Göteborg University / Malmö University
name: Tomas Albrektsson, MD PhD
role: STUDY_CHAIR
affiliation: Region Skåne
name: Jenö Kisch, DDS
role: STUDY_DIRECTOR
References: