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Completed

NCT Number: NCT06083246

Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybenix gel

Other

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

Chlosite gel

Other

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

Primary outcomes

  1. Change in BOP - Bleeding On Probing

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

    Dichotomous scoring (yes/no)

  2. 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.

  3. Change in marginal mucosa condition

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

    Scoring criteria:

    0: normal mucosa

    • minimal inflammation with color change and minor edema
    • moderate inflammation with redness, edema and glazing
    • severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing

  4. Change in suppuration

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

    Dichotomous scoring (yes/no)

  5. Marginal mucosal migration

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

    Dichotomous scoring (yes/no)

  6. 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.

  7. Change in BS - Bleeding Score

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

    Scoring criteria:

    0: no bleeding

    • isolated visible spots
    • blood forms a confluent red line on mucosal margin
    • heavy or profuse bleeding

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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