NCT05254288

In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease

Evaluation of a New In-office and Domiciliary Ozonized Gel for the Management of Periodontal Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease. Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design: the Control Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4), while for the Trial Group Ozoral Pro for quadrants 2/4 (or 1/3) will be used. Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications. The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.

Detailed description

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease comparing chlorhexidine and ozone gels. Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design: * Control Group: application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4) * Trial Group: administration of Ozoral Pro for quadrants 2/4 (or 1/3). Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications. The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
OTHER	Chlorhexidine	In-office and domiciliary use of chlorhexidine for 14 days.
OTHER	Ozoral gels	In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.

Timeline

• Start date: 2022-03-22
• Primary completion: 2022-10-15
• Completion: 2022-10-19
• First posted: 2022-02-24
• Last updated: 2022-10-20

Locations

1 site across 1 country: Italy