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

University of Pavia

Status: Completed

Conditions: Periodontal Diseases

Treatments: Other: Unidea Chlorhexidine digluconate mouthwash 0.20%; Other: Aftoral Oral gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05312606

2022-AFTORAL PARO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• presence of stage II periodontitis sistes according to the 2017 World Workshop classification system
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Trial Group

Experimental group

Description:

Home treatment with hyaluronic acid.

Treatment:

Other: Aftoral Oral gel

Control Group

Active Comparator group

Description:

Home treatment with chlorhexidine.

Treatment:

Other: Unidea Chlorhexidine digluconate mouthwash 0.20%