Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

NCT ID: NCT06083246

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2025-11-10

Brief Summary

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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

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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

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hybenix gel

Clinical application of Hybenix gel.

Group Type EXPERIMENTAL

Hybenix gel

Intervention Type OTHER

Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.

Chlosite

Clinical application of Chlosite gel.

Group Type ACTIVE_COMPARATOR

Chlosite gel

Intervention Type OTHER

Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.

Interventions

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Hybenix gel

Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.

Intervention Type OTHER

Chlosite gel

Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2023-IMPLGEL

Identifier Type: -

Identifier Source: org_study_id

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