An Exploratory Clinical Investigation Evaluating Two Abutment Surfaces

NCT ID: NCT06557447

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-04-30

Brief Summary

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.

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.

Conditions

Peri-implant Crevicular Fluid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation

Intervention Type: DIAGNOSTIC_TEST

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.

Control Group

Subjects treated in 2017 with NobelActive TiUnite implant and On1 machined abutment on a previous clinical study protocol approaved by Ethics Committee.

Group Type: OTHER

Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Studio Ban Mancini Fabbri

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Efontanarosa

Identifier Type: -

Identifier Source: org_study_id