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

NCT ID: NCT05926297

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peri-implant Mucositis Mucositis Oral

Keywords

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Hyaluronic Acid Peri-implant mucositis Sodium hypochlorite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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

Study Groups

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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.

Group Type EXPERIMENTAL

Application NaOCl gel + HA gel

Intervention Type PROCEDURE

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

NSMD Group

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

Group Type ACTIVE_COMPARATOR

Non-surgical mechanical debridement

Intervention Type PROCEDURE

Only mechanical debridement with curettes ans scaler tips

Interventions

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Application NaOCl gel + HA gel

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

Intervention Type PROCEDURE

Non-surgical mechanical debridement

Only mechanical debridement with curettes ans scaler tips

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role collaborator

Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Luca Ramaglia

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luca Ramaglia

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Semmelweis University

Budapest, HU, Hungary

Site Status

University of Naples Federico II

Naples, Italy, Italy

Site Status

Countries

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Hungary Italy

Other Identifiers

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140/2023

Identifier Type: OTHER

Identifier Source: secondary_id

110/2023

Identifier Type: -

Identifier Source: org_study_id