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

Periodontal Diseases Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Periodontal Diseases

• NCT number: NCT05312606
• Study type: Interventional
• Source: University of Pavia
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Completion date: November 5, 2022