Clinical trial NCT05188898: Treatment of Intraosseous Periodontal Defects With Hyaluronic Acid
Official title: Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Hyaluronic Acid. A Randomized-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Bone Loss
Periodontal Pocket
Keywords: Hyaluronic Acid
Periodontal therapy
Periodontal Bone Loss
Intraosseous Bone Defect
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Probing Depth (PD) (millimeters)
timeFrame: baseline and 6 months after periodontal therapy
Secondary outcomes:
measure: Change of Clinical Attachment Level (CAL) gain (millimeters)
timeFrame: baseline and 6 months after periodontal therapy
measure: Change of Gingival Recession (GR) (millimeters)
timeFrame: baseline and 6 months after periodontal therapy
measure: Change of Radiographic Defect Angle (RDA) (grade °)
timeFrame: baseline and 6 months after periodontal therapy
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References: