NCT06083246

Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

Efficacy of Hybenix and Chlosite Gels in Peri-implantitis Sites: a 9-month Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peri-Implantitis

Interventions

Type	Name	Description
OTHER	Hybenix gel	Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.
OTHER	Chlosite gel	Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.

Timeline

• Start date: 2023-10-10
• Primary completion: 2025-10-20
• Completion: 2025-11-10
• First posted: 2023-10-13
• Last updated: 2025-11-18

Locations

1 site across 1 country: Italy