NCT02374216

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

3.9 years

First QC Date

February 10, 2015

Last Update Submit

March 5, 2019

Conditions

Keywords

Dental ImplantsPeriodontal Bone LossImplant-Supported Dental ProsthesisDental Prosthesis Failure

Outcome Measures

Primary Outcomes (1)

  • Survival of implants

    Time from the surgical placement of implants until the last follow-up visit or until its failure

    Up to 3 years

Secondary Outcomes (2)

  • Marginal bone loss

    Up to 3 years

  • Dental prosthesis complications

    Up to 3 years

Study Arms (1)

Dental implants

OTHER

Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 and August 31st 2017

Procedure: Insertion of dental implants

Interventions

Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 to August 31st 2017

Also known as: Dental implant surgical placement
Dental implants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folktandvården Specialistklinik

Malmo, Skåne County, 214 27, Sweden

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Bruno R Chrcanovic, DDS MSc

    Malmö University

    PRINCIPAL INVESTIGATOR
  • Ann Wennerberg, DDS PhD

    Malmö University

    STUDY CHAIR
  • Tomas Albrektsson, MD PhD

    Göteborg University / Malmö University

    STUDY CHAIR
  • Jenö Kisch, DDS

    Region Skåne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MSc, PhD student

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 27, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations