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

NCT05122897 | Recruiting

• 1 other identifier: 2021-D0061; ex21Zitzmann
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Plaque; Oral Biofilm; Peri-implantitis

Keywords

Titanium-6Aluminum-7Niobium alloy; Pagalinor; transmucosal implant abutment; implant crowns; temporary push-on rings; Variobase abutments

Outcome Measures

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.

  at 48 hours after ring placement, 2 weeks after ring placement and 3 months after ring placement

Secondary Outcomes (5)

• Change in bacterial composition (taxonomic diversity) between different materials at various time points by using metagenomic sequencing analysis

  at baseline, 2 weeks after ring placement and 10 weeks after ring placement

• Change in probing pocket depth (PPD) in mm

  at baseline, 2 weeks after ring placement and 10 weeks after ring placement

• Change in bleeding on probing (BoP)

  at baseline, 2 weeks after ring placement and 10 weeks after ring placement

• Change in noninvasive laser doppler flowmetry

  at baseline, 2 weeks after ring placement and 10 weeks after ring placement

• Change in the cells of the peri-implant soft tissue

  at 2 weeks after ring placement

Study Arms (2)

Pagalinor®2 (PA) test arm

EXPERIMENTAL

All patients will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner.

Device: Rings made of PA (test)

Titanium-6Aluminum- 7Niobium alloy (TAN) control arm

ACTIVE COMPARATOR

All patients will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner.

Device: Rings made of TAN (control)

Interventions

Rings made of PA (test) DEVICE

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).

Pagalinor®2 (PA) test arm

Rings made of TAN (control) DEVICE

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).

Titanium-6Aluminum- 7Niobium alloy (TAN) control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

UZB (University Center for Dental Medicine Basel)

Basel, 4058, Switzerland

RECRUITING

MeSH Terms

Conditions

Dental Plaque; Peri-Implantitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Nicola U. Zitzmann, Prof. Dr.

  University Center for Dental Medicine Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola U. Zitzmann, Prof. Dr.

CONTACT

+41 61 267 26 36; n.zitzmann@unibas.ch

Lucia K. Zaugg, Dr. med. dent.

CONTACT

+41 61 267 26 36; lucia.zaugg@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded with the patient not knowing which material is placed, and the investigator and laboratory technicians have no information about the ring material.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients enrolled in the current investigation will wear both the test and control ring material for a within-subject comparison. Ideally, biofilm sampling can be performed in a split mouth design (randomly allocated materials within subjects) with one patient having two implants for placing the test and the control material at the same time. In addition, patients providing one implant, will receive test and control push-on rings in a randomly assigned order, so that both materials are assessed in a consecutive manner.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 17, 2021
• Study Start: January 11, 2022
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

CH (1)