NCT05312606

Hyaluronic Gel vs Chlorhexidine in Periodontal Patients

Efficacy of a Hyaluronic Acid-Based Gel Versus 0.20% Chlorhexidine in Non-Surgical Periodontal Therapy: A Single-Blind Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled clinical trial (RCT) aims to evaluate the adjunctive efficacy of two domiciliary treatments in patients with periodontitis undergoing non-surgical periodontal therapy. After signing the informed consent, patients satisfying the inclusion criteria will undergo professional supragingival and subgingival periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder. After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy: * Aftoral® Oral Gel containing hyaluronic acid, xylitol, and glycerophosphoinositol, applied domiciliary for 15 days. * Unidea® chlorhexidine digluconate mouthwash 0.20%, used as a domiciliary rinse for 15 days. The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3). Professional oral hygiene procedures will be repeated at T2 and T3. At each visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site: * Gingival Recession (GR) * Probing Pocket Depth (PPD) * Bleeding on Probing (BoP) * Clinical Attachment Level (CAL) * Plaque Control Record (PCR) * Tooth Mobility (TM)

Detailed description

This is a randomized controlled clinical trial (RCT). A total of 40 patients with periodontitis are expected to be enrolled. After providing written informed consent, patients meeting the inclusion criteria will undergo supragingival and subgingival professional periodontal debridement of both arches performed using 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, University of Pavia (Italy). After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy: * Aftoral® Oral Gel, containing hyaluronic acid, xylitol and glycerophosphoinositol, applied as domiciliary treatment for 15 days. * Unidea® chlorhexidine digluconate mouthwash 0.20%, used as domiciliary rinse for 15 days. The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3). Professional oral hygiene procedures will be repeated at T2 and T3. At each follow-up visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site: * Gingival Recession (GR) * Probing Pocket Depth (PPD) * Bleeding on Probing (BoP) * Clinical Attachment Level (CAL) * Plaque Control Record (PCR) * Tooth Mobility (TM)

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
OTHER	Aftoral Oral gel	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).
OTHER	Unidea Chlorhexidine digluconate mouthwash 0.20%	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).

Timeline

• Start date: 2022-04-04
• Primary completion: 2022-11-01
• Completion: 2022-11-05
• First posted: 2022-04-05
• Last updated: 2026-03-25

Locations

1 site across 1 country: Italy