An interventional study of MINSD and Hyaluronic acid and MINSD in Periodontal Bone Loss and Periodontal Pocket, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Federico II University · Not applicable, Interventional, and Treatment
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.
304 studies on the registry are indexed under Alveolar Bone Loss; 77 are open to participants now.
This study's enrollment of 22 is below the median of 25 across 261 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Hyaluronic acid gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD)
Other: MINSD and Hyaluronic acid
Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed
Other: MINSD
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.
Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Change of Probing Depth (PD) (millimeters)
Distance from the gingival margin to the bottom of the pocket
Time frame: baseline and 6 months after periodontal therapy
Change of Clinical Attachment Level (CAL) gain (millimeters)
Distance from the Cement Enamel Junction (CEJ) to the bottom of the pocket
Time frame: baseline and 6 months after periodontal therapy
Change of Gingival Recession (GR) (millimeters)
Distance from gingival margin to the cementoenamel junction
Time frame: baseline and 6 months after periodontal therapy
Change of Radiographic Defect Angle (RDA) (grade °)
Radiographic intraosseous angle
Time frame: baseline and 6 months after periodontal therapy
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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