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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05188898
Other study ID # 141/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 12, 2022
Est. completion date March 8, 2023

Study information

Verified date April 2024
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 8, 2023
Est. primary completion date March 8, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients diagnosed with periodontitis; - Age = 18 years old; - Presence of at least 10 teeth per arch; - Presence of at least two teeth with Probing Depth (PD) = 5 mm per quadrant; - Presence of at least one intraosseous pocket; - Single-rooted and multi-rooted teeth. Exclusion Criteria: - Patients with systemic diseases; - Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy; - Pregnant or lactating; - Tobacco smokers (= 10 cigarettes per day); - Multi-rooted teeth with furcation involvement; - Third molars.

Study Design


Intervention

Other:
MINSD and Hyaluronic acid
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.
MINSD
Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.

Locations

Country Name City State
Italy University of Naples Federico II Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Probing Depth (PD) (millimeters) Distance from the gingival margin to the bottom of the pocket baseline and 6 months after periodontal therapy
Secondary 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
Secondary Change of Gingival Recession (GR) (millimeters) Distance from gingival margin to the cementoenamel junction baseline and 6 months after periodontal therapy
Secondary Change of Radiographic Defect Angle (RDA) (grade °) Radiographic intraosseous angle baseline and 6 months after periodontal therapy
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