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| ID | Type | Description | Link |
|---|---|---|---|
| 140/2023 | Other Identifier | Semmelweis University, Faculty of Dentistry |
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| Name | Class |
|---|---|
| Semmelweis University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| NSMD Group | Active Comparator | Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application NaOCl gel + HA gel | Procedure | First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of BoP (+/-) | Bleeding on periodontal probing | baseline, 6 months after periodontal therapy |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Ramaglia | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University | Budapest | HU | Hungary | |||
| University of Naples Federico II |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41761442 | Derived | 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. |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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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.
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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
| Non-surgical mechanical debridement | Procedure | Only mechanical debridement with curettes ans scaler tips |
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| 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 |
| Naples |
| Italy |
| 80131 |
| Italy |