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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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)
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.
|
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.
|
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
Time Frame: 2 samples collections with 3 weeks of interval
|
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
Time Frame: 2 samples collections with 3 weeks of interval
|
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
Time Frame: Pre-treatment/initial visit
|
Bleeding on probing will be assessed on implant and contralateral tooth/implant for test and control group
|
Pre-treatment/initial visit
|
|
Gingival Index
Time Frame: Pre-treatment/initial visit
|
Gingival status will be assessed on implant and contralateral tooth/implant for test and control group
|
Pre-treatment/initial visit
|
|
Plaque Index
Time Frame: Pre-treatment/initial visit
|
Dental plaque will be assessed on implant and contralateral tooth/implant for test and control group
|
Pre-treatment/initial visit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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