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

NCT05926297 | Completed DMC

• 2 other identifiers: 110/2023140/2023
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Peri-implant Mucositis; Mucositis Oral

Keywords

Hyaluronic Acid; Peri-implant mucositis; Sodium hypochlorite

Outcome Measures

Primary Outcomes (1)

• Change of BoP (+/-)

  Bleeding on periodontal probing

  baseline, 6 months after periodontal therapy

Secondary Outcomes (3)

• Change of Full-mouth Plaque Score (FMPS; %)

  baseline, 6 months after periodontal therapy

• Change of Full-mouth Bleeding Score (FMBS; %)

  baseline, 6 months after periodontal therapy

• Change of Probing Depth (PD; millimeters).

  baseline, 6 months after periodontal therapy

Study Arms (2)

NaOCl + HA Group

EXPERIMENTAL

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

NSMD Group

ACTIVE COMPARATOR

Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.

Procedure: Non-surgical mechanical debridement

Interventions

Application NaOCl gel + HA gel PROCEDURE

First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel

NaOCl + HA Group

Non-surgical mechanical debridement PROCEDURE

Only mechanical debridement with curettes ans scaler tips

NSMD Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead
• Semmelweis University: collaborator

Study Sites (2)

Semmelweis University

Budapest, HU, Hungary

Location

University of Naples Federico II

Naples, Italy, 80131, Italy

Location

Related Publications (1)

• Iorio-Siciliano V, Blasi A, Mauriello L, Windisch P, Salvi GE, Sculean A, Ramaglia L. Non-Surgical Submarginal Instrumentation of Peri-Implant Mucositis With Delivery of Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Feb 27. doi: 10.1111/clr.70109. Online ahead of print.

  PMID: 41761442 DERIVED

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Luca Ramaglia

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with NaOCl-based gel + NSMD + HA-based gel in Test group and with NSMD alone in Control group. All clinical parameters will be recorded and the final evaluation will be performed.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: June 6, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); HU (1)