RecruitingNot ApplicableNCT05122897

Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns

Temporary push-on Rings of Antimicrobial Alloys for Transmucosal Implant Abutment Systems: a Randomized Clinical Study on Early and Mature Biofilm Formation

Sponsor

University Hospital, Basel, Switzerland

Enrollment

33 participants

Start Date

Jan 11, 2022

Study Type

INTERVENTIONAL

Conditions

Peri-implantitis Oral Biofilm Dental Plaque

Summary

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

Min Age: 18 Years

Inclusion Criteria7

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)
No pregnancy
No active periodontitis (probing pocket depth ≤4 mm)
No pharmacological treatment or antibiotic therapy during or up to three months before the study

Exclusion Criteria6

Systemic illness (e.g. Diabetes)
Heavy smoking (smoking \>10 cigarettes/day)
Known or suspected non-compliance, drug or alcohol abuse
Pregnancy
Active periodontitis (probing pocket depth \>4 mm)
Pharmacological treatment or antibiotic therapy during or up to three months before the study

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Interventions

DEVICERings made of PA (test)

Rings 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).

DEVICERings made of TAN (control)

Rings 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).