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An Exploratory Clinical Investigation Evaluating Two Abutment Surfaces

NCT06557447 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-08-16

No results posted yet for this study

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.

Conditions

  • Peri-implant Crevicular Fluid

Interventions

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.

Sponsors & Collaborators

  • Studio Ban Mancini Fabbri

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-01-31
Completion
2025-04-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06557447 on ClinicalTrials.gov