Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
This in-vivo study investigates early (48h), mature (2 weeks) and long-term (3 months) biofilm formation and composition on temporary push-on cones (exchangeable conical rings) made of noble-alloy-based materials (Pagalinor, PA) in comparison to Titanium-6Aluminum-7Niobium alloy (TAN) presently used in the transmucosal portion of dental implant abutments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Informed Consent signed by the subject
Presence of one or more bone level titanium implant prior to insertion of the final restoration
No systemic illness
No heavy smoking (smoking <10 cigarettes/day)
Disqualifiers
Systemic illness (e.g. Diabetes)
Heavy smoking (smoking >10 cigarettes/day)
Known or suspected non-compliance, drug or alcohol abuse
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Rings made of PA (test)
DeviceRings made of PA (test) 0.2mm in thickness are pushed on the conical titanium base (abutment) of implant crowns and are removed and replaced after 48h, 2 weeks and 3 months for quantification of the bacterial biofilm. Test rings are applied in a split-mouth design provided that 2 implants are present (total of 4 months study period), or one after the other when only 1 implant is present (total of 8 months study period).
Rings made of TAN (control)
DeviceRings made of TAN (control) 0.2mm in thickness are pushed on the conical titanium base (abutment) of implant crowns and are removed and replaced after 48h, 2 weeks and 3 months for quantification of the bacterial biofilm. Control rings are applied in a split-mouth design provided that 2 implants are present (total of 4 months study period), or one after the other when only 1 implant is present (total of 8 months study period).
Treatment groups
33 Participants
are divided into 2 treatment groupsGroup A: Pagalinor®2 (PA) test armExperimental treatment 1 intervention
Group B: Titanium-6Aluminum- 7Niobium alloy (TAN) control armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in total bacterial load formed on the removable rings of each material
Quantification of the bacterial load formed on the removable rings of each material by quantitative real-time PCR (qPCR) using primers specific to highly conserved regions of bacterial 16S rRNA genes.
Time frame
at 48 hours after ring placement, 2 weeks after ring placement and 3 months after ring placementSecondary outcomes
1
Change in bacterial composition (taxonomic diversity) between different materials at various time points by using metagenomic sequencing analysis
To assess differences in bacterial composition (taxonomic diversity) between different materials at various time points by Illumina MiSeq sequencing. The taxonomy of each 16S rRNA gene sequence will be analyzed by Ribosomal Database Project (RDP) Classifier (http://rdp.cme.msu.edu/) against the SILVA (SSU123) 16S rRNA database using a confidence threshold of 70%.
Time frame
at baseline, 2 weeks after ring placement and 10 weeks after ring placement2
Change in probing pocket depth (PPD) in mm
Change in probing pocket depth (PPD) to investigate the inflammatory tissue response
Time frame
at baseline, 2 weeks after ring placement and 10 weeks after ring placement3
Change in bleeding on probing (BoP)
Recording bleeding on probing (BoP) to investigate the inflammatory tissue response
Time frame
at baseline, 2 weeks after ring placement and 10 weeks after ring placement4
Change in noninvasive laser doppler flowmetry
Change in noninvasive laser doppler flowmetry to to measure the blood flow of mucosa next to the ring
Time frame
at baseline, 2 weeks after ring placement and 10 weeks after ring placementSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
ITI International Team for Implantology, Switzerland
Collaborator
Source ClinicalTrials.gov