Peri-implant MucositisNCT05926297
Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
A study testing Application NaOCl gel + HA gel and Non-surgical mechanical debridement in people with Peri-implant Mucositis and Mucositis Oral, run by Federico II University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Mucositis Oral
- What is being tested?
- Application NaOCl gel + HA gel and Non-surgical mechanical debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jun 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
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.
Read the 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.
- Conditions
- Peri-implant Mucositis, Mucositis Oral
- Being tested
- Application NaOCl gel + HA gel, Non-surgical mechanical debridement
- Keywords
- Hyaluronic Acid, Peri-implant mucositis, Sodium hypochlorite
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application NaOCl gel + HA gelProcedure or surgery
First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel
Non-surgical mechanical debridementProcedure or surgery
Only mechanical debridement with curettes ans scaler tips
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Non-surgical mechanical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of BoP (+/-)
Bleeding on periodontal probing
Measured: baseline, 6 months after periodontal therapy
Secondary outcomes (3)
Change of Full-mouth Plaque Score (FMPS; %)
Percentage of all sites exhibiting plaque
Measured: baseline, 6 months after periodontal therapy
Change of Full-mouth Bleeding Score (FMBS; %)
Percentage of all sites exhibiting bleeding
Measured: 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
Measured: baseline, 6 months after periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start6 Jun 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University
- Responsible party
- Principal investigator, Luca Ramaglia, Federico II University
- Investigators
- Luca Ramaglia, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926297
- Sponsor's protocol ID
- 110/2023
- Other IDs
- 140/2023
- Status last verified
- Mar 2025
- First submitted
- 22 Jun 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 May;37(5):643-656. doi: 10.1111/clr.70109. Epub 2026 Feb 27.
PubMed 41761442
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05926297
- Acronym / sponsor ID
- 110/2023
- Conditions
- Peri-implant Mucositis, Mucositis Oral
- Keywords
- Hyaluronic Acid, Peri-implant mucositis, Sodium hypochlorite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- Semmelweis University
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NaOCl + HA Group | Experimental | Procedure: Application NaOCl gel + HA gelA 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. |
| NSMD Group | Active comparator | Procedure: Non-surgical mechanical debridementControl group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application NaOCl gel + HA gelFirst step: application of NaOCl gel Second step: NSMD Third step: application of HA gel | Procedure or surgery | NaOCl + HA Group |
| Non-surgical mechanical debridementOnly mechanical debridement with curettes ans scaler tips | Procedure or surgery | NSMD Group |
Primary outcome
Change of BoP (+/-)
Time frame: baseline, 6 months after periodontal therapy
Bleeding on periodontal probing
3 secondary outcomes
Change of Full-mouth Plaque Score (FMPS; %)
Time frame: baseline, 6 months after periodontal therapy
Change of Full-mouth Bleeding Score (FMBS; %)
Time frame: baseline, 6 months after periodontal therapy
Change of Probing Depth (PD; millimeters).
Time frame: baseline, 6 months after periodontal therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 41761442Iorio-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 May;37(5):643-656. doi: 10.1111/clr.70109. Epub 2026 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Ramaglia principal investigator
Federico II University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application NaOCl gel + HA gel and Non-surgical mechanical debridement in people with Peri-implant Mucositis and Mucositis Oral, run by Federico II University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of BoP (+/-) (time frame: baseline, 6 months after periodontal therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05926297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.