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Completed

NCT Number: NCT05312606

Hyaluronic Gel vs Chlorhexidine in Periodontal Patients

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)

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aftoral Oral Gel

Other

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).

Unidea Chlorhexidine digluconate mouthwash 0.20%

Other

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).

Primary outcomes

  1. Change in Probing Pocket Depth (PPD)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

    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.

  2. Gingival Recession (R)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

    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.

  3. Change in Bleeding on Probing (BOP%)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

    Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total).

    Formula = n ° bleeding sites / n ° probed sites x100

  4. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

    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.

  5. Change in Plaque Control Record (PCR%)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

    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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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