Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

October 31, 2023 updated by: Andrea Scribante, University of Pavia

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybenix gel
Clinical application of Hybenix gel.
Other: Hybenix gel
Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.
Active Comparator: Chlosite
Clinical application of Chlosite gel.
Other: Chlosite gel
Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BOP - Bleeding On Probing
Time Frame: Baseline, 1, 3, 6 and 9 months.
Dichotomous scoring (yes/no)
Baseline, 1, 3, 6 and 9 months.
Change in GBI - Gingival Bleeding Index (percentage)
Time Frame: Baseline, 1, 3, 6 and 9 months.

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
Time Frame: Baseline, 1, 3, 6 and 9 months.

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
Time Frame: Baseline, 1, 3, 6 and 9 months.
Dichotomous scoring (yes/no)
Baseline, 1, 3, 6 and 9 months.
Marginal mucosal migration
Time Frame: Baseline, 1, 3, 6 and 9 months.
Dichotomous scoring (yes/no)
Baseline, 1, 3, 6 and 9 months.
Probing Depth
Time Frame: Baseline, 1, 3, 6 and 9 months.
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
Time Frame: Baseline, 1, 3, 6 and 9 months.

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)
Time Frame: Baseline, 1, 3, 6 and 9 months.
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)
Time Frame: Baseline, 1, 3, 6 and 9 months.
Quantitative evaluation of the bone loss evaluated on intraoral x-rays.
Baseline, 1, 3, 6 and 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Andrea Scribante, DDS, PhD, MSc, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

October 20, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-IMPLGEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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