Initial Fixation of Bisphosphonate-coated Dental Implants

June 8, 2015 updated by: Per Aspenberg
16 patients will be included. Each patient receives 2 dental implants. One of them is coated with a drug, zoledronate, to improve fixation. Fixation is measured by vibration resonance frequency analysis at insertion and 2, 4, 6 and 8 weeks after insertion.The 2 implants in each patient are compared. We expect to find an early improvement (higher resonance frequency) in the coated implant.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The zoledronate is linked to the titanium implant surface via a nanolayer of crosslinked fibrinigen. Resonance frequency is measured with standard clinical equipment (Ostell apparatus).

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 58185
        • Recruiting
        • Käkcentralen
        • Contact:
        • Principal Investigator:
          • Jahan Abtahi, MD PhD
      • Linköping, Sweden, 58227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Need for dental implant in upper jaw. CTscan showing at least 6 mm bucco-lingual thickness. Generally healthy

Exclusion Criteria:

Drugs or conditions that influence or are thought to influence bone healing, such as bisphosphonates, corticosteroids, other oral pathologies, severe autoimmune diseases, cancer. Osteoporosis is not cause for exclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bisphosphonate implant
Dental implant coated with zoledronate Note: Both arms in each patient (2 implants)
Device: Zoledronate-coated dental implant
Placebo Comparator: control
Dental implant without coating Note: Both arms in each patient (2 implants)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vibration frequency ratio
Time Frame: 4 and 6 weeks
Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for 4 and 6 weeks will be used.
4 and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal resorption
Time Frame: 8 weeks
Radiographic loss of bone at the margin of the implant, measured as difference in mm from the superficial bone contour between insertion and 8 weeks.
8 weeks
Vibration: area under the curve
Time Frame: 2-8 weeks
Each patients has a study implant and a control implant. Their change vibation frequency from insertion till measurement time point is measured and the ratio between changes for the 2 implants forms the outcome measure. Avarage values for all weeks will be used.
2-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Aspenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tandskruv tidsserie

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pre-integration Failure of Dental Implant

Clinical Trials on Zoledronate-coated dental implant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe