Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

University of Pavia

Status: Completed

Conditions: Peri-Implantitis

Treatments: Other: Chlosite gel; Other: Hybenix gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06083246

2023-IMPLGEL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- Presence of at least one peri-implant site with perimplantitis diagnosed according to the latest Classification of Periodontal and Peri-Implant Diseases and Conditions [Berglundh et al., 2018]

Exclusion criteria

• Patient with cardiac pacemaker
• Patients suffering from psychological, neurological or psychiatric disorders
• Patients suffering from systemic, metabolic or autoimmune diseases
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Hybenix gel

Experimental group

Description:

Clinical application of Hybenix gel.

Treatment:

Other: Hybenix gel

Chlosite

Active Comparator group

Description:

Clinical application of Chlosite gel.

Treatment:

Other: Chlosite gel