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Hyaluronic Gel vs Chlorhexidine in Periodontal Patients

NCT05312606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-25

No results posted yet for this study

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)

Conditions

  • Periodontal Diseases

Interventions

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).

Sponsors & Collaborators

  • University of Pavia

    lead OTHER

Principal Investigators

  • Andrea Scribante, DDS, PhD, MS · University of Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-04
Primary Completion
2022-11-01
Completion
2022-11-05

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05312606 on ClinicalTrials.gov