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Completed

NCT Number: NCT05926297

Treatment of Peri-implant Mucositis by 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Budapest, HU, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Application NaOCl gel + HA gel

Procedure

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

Non-surgical mechanical debridement

Procedure

Only mechanical debridement with curettes ans scaler tips

Primary outcomes

  1. Change of BoP (+/-)

    Time frame: baseline, 6 months after periodontal therapy

    Bleeding on periodontal probing

Secondary outcomes

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

    Time frame: baseline, 6 months after periodontal therapy

    Percentage of all sites exhibiting plaque

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

    Time frame: baseline, 6 months after periodontal therapy

    Percentage of all sites exhibiting bleeding

  3. Change of Probing Depth (PD; millimeters).

    Time frame: baseline, 6 months after periodontal therapy

    Distance from the gingival margin to the bottom of the peri-implant pocket

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • Semmelweis University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
Dec 24, 2025

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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