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NOT YET RECRUITING
NCT06557447
NA

An Exploratory Clinical Investigation Evaluating Two Abutment Surfaces

Sponsor: Studio Ban Mancini Fabbri

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2024-12

Completion Date

2025-04

Last Updated

2024-08-16

Healthy Volunteers

Yes

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.