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Clinical Trial Summary

The present study is a randomized clinical trial (RCT). Patients responding to the inclusion criteria will be included. The following peri-implant indexes will be collected: Bleeding On Probing, Gingival Bleeding Index, Marginal Mucosal Conditions (swelling and erythema), Suppuration, Mucosal margin migration, PPD Probing Pocket Depth, Plaque Index, Bleeding Score, radiographic bone loss. After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder. After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment: - Chlosite® gel application in the peri-implant sulcus - Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus. The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4). In each time frame, indexes collection and nonsurgical debridement will be performed.


Clinical Trial Description

The present study is designed as a randomized clinical trial (RCT) to evaluate the clinical efficacy of two adjuvant gels in the treatment of perimplantitis. Patients responding to the inclusion criteria will be included in the study. The following peri-implant indexes will be collected: - BOP (Bleeding On Probing) - GBI (Gingival Bleeding Index) - Marginal Mucosal Conditions (swelling and erythema) - Suppuration - Mucosal margin migration - PPD (Probing Pocket Depth) - PI (Plaque Index) - BS (Bleeding Score) - Radiographic bone loss After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder. After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment: - Chlosite® gel application in the peri-implant sulcus - Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus. The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4). In each time frame, indexes collection and nonsurgical debridement will be performed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06083246
Study type Interventional
Source University of Pavia
Contact
Status Enrolling by invitation
Phase N/A
Start date October 10, 2023
Completion date October 30, 2024

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