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

Treatment of Peri-implant Mucositis by Non-surgical Debridement and Adjunctive Application of a Combination of Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel

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.

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis; Mucositis Oral
• Intervention / Treatment: Procedure: Application NaOCl gel + HA gel; Procedure: Non-surgical mechanical debridement

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • HU
    • Budapest, HU, Hungary
      • Semmelweis University
• Italy
  • Italy
    • Naples, Italy, Italy, 80131
      • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥ 18 years;
• Non-smokers and smokers ( ≤ 10 cigarettes/day);
• Presence of at least 1 implant in mucositis, clinically and radiographically detected;
• The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed.

Exclusion Criteria:

• Cancer patients;
• Uncontrolled diabetic patients;
• Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months;
• Pregnant or breastfeeding patients;
• Implants that support mobile prosthetic products;
• Implants in peri-implantitis, detected clinically and radiographically.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NaOCl + HA 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, the HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle.	Procedure: Application NaOCl gel + HA gel; First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel
Active Comparator: NSMD Group; Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.	Procedure: Non-surgical mechanical debridement; Only mechanical debridement with curettes ans scaler tips

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of BoP (+/-)	Bleeding on periodontal probing	baseline, 6 months after periodontal therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Full-mouth Plaque Score (FMPS; %)	Percentage of all sites exhibiting plaque	baseline, 6 months after periodontal therapy
Change of Full-mouth Bleeding Score (FMBS; %)	Percentage of all sites exhibiting bleeding	baseline, 6 months after periodontal therapy
Change of Probing Depth (PD; millimeters).	Distance from the gingival margin to the bottom of the peri-implant pocket	baseline, 6 months after periodontal therapy

Collaborators and Investigators

• Sponsor: Federico II University
• Collaborators: Semmelweis University
• Investigators: Principal Investigator: Luca Ramaglia, Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Hyaluronic Acid; Sodium hypochlorite; Peri-implant mucositis
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis
• Other Study ID Numbers: 110/2023; 140/2023 (Other Identifier: Semmelweis University, Faculty of Dentistry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No