Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rings made of PA (test), Rings made of TAN (control).
- Who it may be relevant to
- Registry conditions: Dental Plaque, Oral Biofilm, Peri-implantitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Temporary push-on Rings of Antimicrobial Alloys for Transmucosal Implant Abutment Systems: a Randomized Clinical Study on Early and Mature Biofilm Formation
Overview
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.
Detailed description
Oral biofilm (dental plaque) consists of bacteria and their metabolic products as well as saliva components and food residues. It is recognizable as a tough and structured coating on teeth and artificial surfaces within the oral cavity. Plaque development is a physiological process that begins immediately after cleaning of the oral surface. If the biofilm is not removed by daily oral hygiene, it continues to mature while changing the structure and its microbial composition.
Implant restorations comprise the osseous implant portion predominantly manufactured from titanium alloys, the transmucosal implant portion (in most implant systems as a separate abutment), and the clinical crown, which is in most systems extraorally cemented on an abutment and screw-retained onto the implant. According to current knowledge, microbial colonization of the implant abutment surface plays a significant role in the aetiology of peri-implantitis.
This study investigates the antibacterial potential of a temporary push-on cone (conical ring) that could reduce the risk of bacterial related peri-implant diseases due to decreased biofilm susceptibility, compared to current available transmucosal materials, in the short- and long-run. The test material Pagalinor®2 (PA) is an established material in dental medicine and has proven to accumulate least biofilm in an in-vivo biofilm sampling model using removable splints. The control material consists of the current transmucosal implant abutment material Titanium-6Aluminum- 7Niobium alloy (TAN). The push-on rings are designed for repeated application along the transmucosal implant abutment portion with high precision fit and will allow biofilm sampling in the natural implant environment. Profound insight into the native homeostasis of biofilm formation will be obtained and therefore enhance the knowledge about long-term tissue response.
Interventions
- Device Rings 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). - Device Rings 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).
Primary outcome measures
- Change in total bacterial load formed on the removable rings of each material [Time frame: at 48 hours after ring placement, 2 weeks after ring placement and 3 months after ring placement]
Secondary outcome measures (5)
- Change in bacterial composition (taxonomic diversity) between different materials at various time points by using metagenomic sequencing analysis [Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement]
- Change in probing pocket depth (PPD) in mm [Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement]
- Change in bleeding on probing (BoP) [Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement]
- Change in noninvasive laser doppler flowmetry [Time frame: at baseline, 2 weeks after ring placement and 10 weeks after ring placement]
- Change in the cells of the peri-implant soft tissue [Time frame: at 2 weeks after ring placement]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Switzerland · 1 center
- UZB (University Center for Dental Medicine Basel) — Basel
Identifiers
NCT: NCT05122897 · 2021-D0061; ex21Zitzmann