Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

NCT06083246 | Completed

• 1 other identifier: 2023-IMPLGEL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-Implantitis

Keywords

Chlorhexidine; Hybenix gel; Domiciliary treatments

Outcome Measures

Primary Outcomes (9)

• Change in BOP - Bleeding On Probing

  Dichotomous scoring (yes/no)

  Baseline, 1, 3, 6 and 9 months.

• Change in GBI - Gingival Bleeding Index (percentage)

  Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.

  Baseline, 1, 3, 6 and 9 months.

• Change in marginal mucosa condition

  Scoring criteria: 0: normal mucosa 1. minimal inflammation with color change and minor edema 2. moderate inflammation with redness, edema and glazing 3. severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing

  Baseline, 1, 3, 6 and 9 months.

• Change in suppuration

  Dichotomous scoring (yes/no)

  Baseline, 1, 3, 6 and 9 months.

• Marginal mucosal migration

  Dichotomous scoring (yes/no)

  Baseline, 1, 3, 6 and 9 months.

• Probing Depth

  Evaluation (in mm) of the depth of the mucosal sulcus, through a millimeter periodontal probe; it is detected from the mucosal margin to the bottom of the peri-implant sulcus, evaluated at 6 sites.

  Baseline, 1, 3, 6 and 9 months.

• Change in BS - Bleeding Score

  Scoring criteria: 0: no bleeding 1. isolated visible spots 2. blood forms a confluent red line on mucosal margin 3. heavy or profuse bleeding

  Baseline, 1, 3, 6 and 9 months.

• Change in PI - Plaque Index (percentage)

  Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.

  Baseline, 1, 3, 6 and 9 months.

• Change in Radiographic bone loss (percentage)

  Quantitative evaluation of the bone loss evaluated on intraoral x-rays.

  Baseline, 1, 3, 6 and 9 months.

Study Arms (2)

Hybenix gel

EXPERIMENTAL

Clinical application of Hybenix gel.

Other: Hybenix gel

Chlosite

ACTIVE COMPARATOR

Clinical application of Chlosite gel.

Other: Chlosite gel

Interventions

Hybenix gel OTHER

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

Hybenix gel

Chlosite gel OTHER

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

Chlosite

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD, MSc

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 13, 2023
• Study Start: October 10, 2023
• Primary Completion: October 20, 2025
• Study Completion: November 10, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)