NCT02044978

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2014

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

January 22, 2014

Last Update Submit

June 8, 2015

Conditions

Pre-integration Failure of Dental Implant

Outcome Measures

Primary Outcomes (1)

  • Vibration frequency ratio

    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 Outcomes (2)

  • Marginal resorption

    8 weeks

  • Vibration: area under the curve

    2-8 weeks

Study Arms (2)

Bisphosphonate implant

ACTIVE COMPARATOR

Dental implant coated with zoledronate Note: Both arms in each patient (2 implants)

Device: Zoledronate-coated dental implant

control

PLACEBO COMPARATOR

Dental implant without coating Note: Both arms in each patient (2 implants)

Interventions

Zoledronate-coated dental implantDEVICE
Bisphosphonate implant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Käkcentralen

Linköping, 58185, Sweden

RECRUITING

Tandläkarhuset

Linköping, 58227, Sweden

RECRUITING

Central Study Contacts

Jahan Abtahi, MD, PhD

CONTACT

jahan.abtahi@lio.se

Per Aspenberg, MD, PhD

CONTACT

per.aspenberg@liu.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

SE(2)