Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients

Study Overview
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Brief Summary
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Brief Summary: This is a randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation, manual instrumentation with Gracey curettes and air polishing with glycine powder. After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment: Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol as a domiciliary application for 15 days. Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary application for 15 days. The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3. At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a Periodontal probe on each site: Gingival Recession (R) PPD (Probing Pocket Depth), BOP% (Bleeding on Probing), CAL (Clinical Attachment Level), PCR% (Plaque Control Record), Tooth Mobility.

Detailed Description
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This is a randomized controlled clinical trial (RCT). 40 patients are expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation, manual instrumentation with Gracey curettes and air polishing with glycine powder. All patients will be treated at the Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences of the University of Pavia. After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment: Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol as a domiciliary application for 15 days. Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary application for 15 days. The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3). At T2 and T3, professional hygiene will be performed again. At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a Periodontal probe on each site: Gingival Recession (R), PPD (Probing Pocket Depth), BOP% (Bleeding on Probing), CAL (Clinical Attachment Level), PCR% (Plaque Control Record), Tooth Mobility.

Official Title
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Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients: a Randomized Clinical Trial

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Other: Aftoral Oral gel
* Other: Unidea Chlorhexidine digluconate mouthwash 0.20%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of periodontitis sites with PPD > 5 mm no systemic, metabolic and autoimmune disease compliant patients Exclusion Criteria: neurologic, psychiatric and mental diseases patients taking bisphosphonates in the last 12 months patients taking antibiotics during the study pregnant and breastfeeding women patients undergoing anticancer treatment

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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No

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Group<br>Home treatment with hyaluronic acid. | Other: Aftoral Oral gel<br>* Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).<br>|
| Active Comparator: Control Group<br>Home treatment with chlorhexidine. | Other: Unidea Chlorhexidine digluconate mouthwash 0.20%<br>* Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Probing Pocket Depth (PPD) | Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites. | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Gingival Recession (R) | Evaluation (in mm) of the displacement of marginal tissue, through a millimeter periodontal probe; it is detected from the cemento-enamel junction (CEJ) to the gingival margin. | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in Bleeding on Probing (BOP%) | Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100 | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in Clinical Attachment Level (CAL) | Evaluation (in mm) of the distance of the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus or periodontal pocket, evaluated in 6 sites. | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in Plaque Control Record (PCR%) | Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100 | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) |