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The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of a hyaluronic acid-based gel, compared to MINSD alone.
A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group (HA) and no-hyaluronic acid group (No-HA).
The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of hyaluronic acid (HA) compared to MINSD alone.
Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of a hyaluronic acid-based gel (HA Group) or MINSD alone (No-HA Group).
Primary outcome will be "Probing Depth" (PD), while the secondary outcomes will be "Clinical Attachment Level" (CAL) gain, "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).
After local anesthesia, in HA group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, a hyaluronic acid-based gel will be applied to the intraosseous periodontal pockets.
In the No-HA group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid Group | Experimental | Hyaluronic acid gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD) |
|
| No-hyaluronic acid Group | Active Comparator | Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINSD and Hyaluronic acid | Other | After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, a hyaluronic acid-based gel will be applied to the intraosseous periodontal pockets. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Probing Depth (PD) (millimeters) | Distance from the gingival margin to the bottom of the pocket | baseline and 6 months after periodontal therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Clinical Attachment Level (CAL) gain (millimeters) | Distance from the Cement Enamel Junction (CEJ) to the bottom of the pocket | baseline and 6 months after periodontal therapy |
| Change of Gingival Recession (GR) (millimeters) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39402910 | Derived | Iorio-Siciliano V, Blasi A, Mauriello L, Salvi GE, Ramaglia L, Sculean A. Non-Surgical Treatment of Moderate Periodontal Intrabony Defects With Adjunctive Cross-Linked Hyaluronic Acid: A Single-Blinded Randomized Controlled Clinical Trial. J Clin Periodontol. 2025 Feb;52(2):310-322. doi: 10.1111/jcpe.14078. Epub 2024 Oct 14. |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in HA group will be treated with MINSD and application of hyaluronic acid, while in No-HA Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.
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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
| MINSD | Other | Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette. |
|
Distance from gingival margin to the cementoenamel junction
| baseline and 6 months after periodontal therapy |
| Change of Radiographic Defect Angle (RDA) (grade °) | Radiographic intraosseous angle | baseline and 6 months after periodontal therapy |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010518 | Periodontitis |