NCT04181099

Brief Summary

The aim is to test the influence of surface finish on biofilm formation on the transmucosal part of zirconia implants in an in vivo study. Sixteen test person will therefore receive an orthodontic apparatus containing the specimens with the respective surfaces and carry them for 2x 24h. The primary outcome is the spectormetrical quantification (OD value) of biofilm on the specimens that have been carried by the test person over 24h. Biofilm will be analysed using scanning electron microscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

November 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

November 26, 2019

Last Update Submit

April 27, 2021

Conditions

Surface Finish

Keywords

dental implantzirconiabiofilm

Outcome Measures

Primary Outcomes (1)

  • Safranin Staining

    The biofilm on the discs is quantified using safranin staining and evaluated with the measurement of optical density using a photospectrometer

    3 months

Secondary Outcomes (1)

  • SEM

    3 months

Study Arms (1)

Zirconia structure

OTHER

The participants will carry an orthodontic device containing 4 discs of differently structured zirconia and titanium to test the biofilm formation in order to determine the ideal structure for the neck area of zirconia dental implants.

Other: Implant neck surface

Interventions

Implant neck surfaceOTHER

The biofilm formation is tested on discs manufactured of zirconia with different surfaces in vivo using orthodontic devices that the participants carry over 24h

Zirconia structure

Eligibility Criteria

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

You may qualify if:

  • No systematic antibiotic therapy during the last 3 months
  • Good oral health and compliance (PI and BI \<20%)
  • No sign of parodontal disease or other inflammatory changes in the mouth
  • Non-smoker

You may not qualify if:

  • Disease that requires antibiotic therapy
  • Pressure marks due to the orthodontic apparatus that can not be eliminated
  • Other unexpected complications that could be related to the orthodontic apparatus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Center for Dental Medicine Basel

Basel, Canton of Basel-City, 4058, Switzerland

Location

Study Officials

  • Jens Fischer, Prof

    University Center for Dental Medicine Basel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 29, 2019

Study Start

January 1, 2020

Primary Completion

June 1, 2020

Study Completion

August 1, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)