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

Peri-implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122897
• Other study ID #: 2021-D0061; ex21Zitzmann
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Nicola U. Zitzmann, Prof. Dr.
• Phone: +41 61 267 26 36
• Email: n.zitzmann[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Plaque
• Oral Biofilm
• Peri-implantitis

Intervention

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).
• 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).

Locations

Country	Name	City	State
Switzerland	UZB (University Center for Dental Medicine Basel)	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	ITI International Team for Implantology, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 48 hours after ring placement, 2 weeks after ring placement and 3 months after ring placement
Secondary	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%.	at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Secondary	Change in probing pocket depth (PPD) in mm	Change in probing pocket depth (PPD) to investigate the inflammatory tissue response	at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Secondary	Change in bleeding on probing (BoP)	Recording bleeding on probing (BoP) to investigate the inflammatory tissue response	at baseline, 2 weeks after ring placement and 10 weeks after ring placement
Secondary	Change in noninvasive laser doppler flowmetry	Change in noninvasive laser doppler flowmetry to to measure the blood flow of mucosa next to the ring	at baseline, 2 weeks after ring placement and 10 weeks after ring placement