Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel

Last updated: May 27, 2025
Sponsor: Federico II University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mucositis

Treatment

Application NaOCl gel + HA gel

Non-surgical mechanical debridement

Clinical Study ID

NCT05926297
110/2023
140/2023
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up. After a meticulous selection, patients will be randomly assigned to Test (Sodium Hypochlorite-based gel + NSMD + Hyaluronic Acid-based gel ) or Control (NSMD) group. All clinical parameters will be recorded and the final evaluation will be performed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years;

  • Non-smokers and smokers ( ≤ 10 cigarettes/day);

  • Presence of at least 1 implant in mucositis, clinically and radiographicallydetected;

  • The implant in mucositis (tissue-level or bone-level) must support a fixedprosthetic device (single crown, 3-element bridge), cemented or screwed.

Exclusion

Exclusion Criteria:

  • Cancer patients;

  • Uncontrolled diabetic patients;

  • Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6months;

  • Pregnant or breastfeeding patients;

  • Implants that support mobile prosthetic products;

  • Implants in peri-implantitis, detected clinically and radiographically.

Study Design

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: Application NaOCl gel + HA gel
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
July 01, 2025

Study Description

The aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel (NaOCl gel) and a cross-linked hyaluronic acid-based gel (HA gel) as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up (Clean & Seal concept). Following the selection through inclusion and exclusion criteria, all patients will be randomly assigned to Test NaOCl-based gel + NSMD + HA-based gel) or Control (NSMD) group.

Patients will be recruited at Department of Periodontology (Univeristy of Naples "Federico II") and at Department of Periodontology (University of Budapest "Semmelweis").

Subsequently, after recording of the clinical parameters (BoP, FMPS, FMBS, PD), in the Test group a NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. Conversely, Control group will be treated only through the NSMD.

All clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again after 6 months for the final evaluation. Data analysis will be performed using statistical software.

Connect with a study center

  • Semmelweis University

    Budapest, HU
    Hungary

    Active - Recruiting

  • University of Naples Federico II

    Naples, 80131
    Italy

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.