University of Naples Federico II
Naples, 80131, Italy
NCT Number: NCT05188898
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).
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Naples, 80131, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline and 6 months after periodontal therapy
Distance from the gingival margin to the bottom of the pocket
Time frame: baseline and 6 months after periodontal therapy
Distance from the Cement Enamel Junction (CEJ) to the bottom of the pocket
Time frame: baseline and 6 months after periodontal therapy
Distance from gingival margin to the cementoenamel junction
Time frame: baseline and 6 months after periodontal therapy
Radiographic intraosseous angle
Federico II University
Other
Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Hyaluronic Acid. A Randomized-controlled Clinical Trial
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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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