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

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)

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Other: Aftoral Oral gel; Other: Unidea Chlorhexidine digluconate mouthwash 0.20%

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)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• presence of periodontitis sites according to the 2017 World Workshop classification system
• absence of systemic, metabolic, or autoimmune diseases
• compliant patients

Exclusion Criteria

• neurological, psychiatric, or mental disorders
• patients taking bisphosphonates within the last 12 months
• patients taking antibiotics during the study period
• pregnant or breastfeeding women
• patients undergoing anticancer treatment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial Group; Home treatment with hyaluronic acid.	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).
Active Comparator: Control Group; Home treatment with chlorhexidine.	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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, MS, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 2022-AFTORAL PARO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data are available upon motivated request to the Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No