Treatment of Intraosseous Periodontal Defects With Hyaluronic Acid

Study Overview
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Brief Summary
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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).

Detailed Description
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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 Clinical Attachment Level (CAL) gain, while the secondary outcomes will be Probing Depth (PD), 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.

Official Title
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Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Hyaluronic Acid. A Randomized-controlled Clinical Trial

Conditions
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Periodontal Bone Loss, Periodontal Pocket

Intervention / Treatment
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* Other: MINSD and Hyaluronic acid
* Other: MINSD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid Group<br>Hyaluronic acid gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD) | Other: MINSD and Hyaluronic acid<br>* 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.<br>|
| Active Comparator: No-hyaluronic acid Group<br>Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed | Other: MINSD<br>* Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Clinical Attachment Level (CAL) gain (millimeters) | Distance from the cementoenamel junction to the bottom of the pocket | baseline and 6 months after periodontal therapy | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Change of Gingival Recession (GR) (millimeters) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic Acid, Periodontal therapy, Periodontal Bone Loss, Intraosseous Bone Defect