An Exploratory Clinical Investigation Evaluating Two Abutment Surfaces (Exploratory)

An Exploratory Clinical Investigation Evaluating Microbiological and Immunological Aspects of Peri-implant Crevicular Fluid and Short-term Treatment Outcomes of Two Different Implant Abutment Surfaces in Subjects Since Four to Nine Years

A total of 22 subjects will be included in the study. The subjects who were treated with NobelActive TiUnite and On1 machined abutment will be enrolled in the control group and subjects who were treated with NobelActive TiUltra and On1 Base Xeal abutments will be enrolled in the test group. Two peri-implant crevicular fluid (PICF) samples will be collected for immunological testing and two plaques samples will be collected for microbiological testing from all the enrolled subjects one from the control/test implant site and one from the contralateral tooth/implant site. 3 weeks after the first sampling PICF and plaques sampling will be repeated the same way.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-implant Crevicular Fluid
• Intervention / Treatment: Diagnostic test: Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation

Detailed Description

The main objective of the study is to evaluate the clinical, microbiological, and immunological biomarkers of implant sites which were treated with two different implant-abutment-systems (anodized surface and machined surface). This single-center exploratory study includes 22 subjects, divided into two distinct groups: Test group and Control group. All subjects in both groups have undergone treatment. In the Test group, subjects were treated between 2019 and 2020 with the NobelActive TiUltra implant and On1 Base Xeal abutment, while in the Control group, treatment occurred in 2017 with NobelActive TiUnite implant and On1 machined abutment. All subjects were treated by the same clinician, Dr Giacomo Fabbri, and were participants in two approved clinical study protocols (T-190 and IIT 2017-1538) approaved by local Ethics Committee. T-190, a multicenter study, involved 21 subjects from Dr Fabbri's center, with 12 subjects available for recall (Control group) in this study. The IIT 2017-1538 study included 61 subjects, with 12 subjects scheduled for recall (Test group) in the current study. Two subjects were part of both the studies, received both the implant abutment solutions and belong to both the groups. The subjects are enrolled provided they meet all the inclusion and none of the exclusion criteria and sign the informed consent. Peri-implant crevicular fluid (PICF) and plaques samples will be collected from control and test implant sites (and respective contralateral tooth/implants) of each participating subject for immunological and microbiological testing at two time points with an interval of approximately 3 weeks between the two sample collections.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects willing to sign the Informed Consent Form
• Subjects able to adhere to the investigation schedule
• Subjects with no previous surgical intervention or soft tissue complications in the area of the implant site (e.g., localized mucositis, mild peri-implantitis, etc.) within 3 months before first sample collection
• Subjects regularly adhere to a professional oral hygiene maintenance program
• No recent antibiotics or biological therapy (or any treatment that activates or suppresses the immune system)
• No xerostomia

Exclusion Criteria:

• Subject not willing to sign the Informed Consent Form
• Subject not able to adhere to the investigation schedule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Test Group; Subjects treated between 2019 and 2020 with the NobelActive TiUltra implant and On1 Base Xeal abutment on a previous clinical study protocol approaved by Ethics Committee.	Diagnostic test: Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation; Immunological sample collection involves placing a Periopaper strip in the peri-implantar sulcus for 30 seconds. If sample is contaminated with blood, sample will be discarded and another sample will be collected (a different surface of the same implant/tooth can be used). Microbiological sample collection involves collecting subgingival dental plaque by sliding the end of the STERILE curette (Gracey) inside the peri-implant sulcus. In case of slight bleeding following the first sample, dry the site again before collection. In case of profuse bleeding, collect a sample from another site (by site mean mesial/buccal/distal/lingual) of the same implant. Both immunological and microbiological samples will be sent for respective laboratories for the analysis. Clinical evaluation will assess presence of dental plaque, bleeding on probing and gingival status.
Other: Control Group; Subjects treated in 2017 with NobelActive TiUnite implant and On1 machined abutment on a previous clinical study protocol approaved by Ethics Committee.	Diagnostic test: Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation; Immunological sample collection involves placing a Periopaper strip in the peri-implantar sulcus for 30 seconds. If sample is contaminated with blood, sample will be discarded and another sample will be collected (a different surface of the same implant/tooth can be used). Microbiological sample collection involves collecting subgingival dental plaque by sliding the end of the STERILE curette (Gracey) inside the peri-implant sulcus. In case of slight bleeding following the first sample, dry the site again before collection. In case of profuse bleeding, collect a sample from another site (by site mean mesial/buccal/distal/lingual) of the same implant. Both immunological and microbiological samples will be sent for respective laboratories for the analysis. Clinical evaluation will assess presence of dental plaque, bleeding on probing and gingival status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate immunological markers in peri-implant crevicular fluid	Immunological sample collection of subgingival area (per-implant crevicular fluid) on implant and contralateral tooth/implant for test and control group	2 samples collections with 3 weeks of interval
Evaluate microbiological response in peri-implant crevicular fluid	Microbiological sample collection of subgingival area (per-implant crevicular fluid) on implant and contralateral tooth/implant for test and control group	2 samples collections with 3 weeks of interval
Bleeding Index	Bleeding on probing will be assessed on implant and contralateral tooth/implant for test and control group	Pre-treatment/initial visit
Gingival Index	Gingival status will be assessed on implant and contralateral tooth/implant for test and control group	Pre-treatment/initial visit
Plaque Index	Dental plaque will be assessed on implant and contralateral tooth/implant for test and control group	Pre-treatment/initial visit

Collaborators and Investigators

• Sponsor: Studio Ban Mancini Fabbri

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Efontanarosa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes