In-office & Domiciliary Use of a New Ozonized Gel for the Management of

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Periodontal Diseases

Clinical Trial Details

NCT number	NCT05254288
Study type	Interventional
Source	University of Pavia
Contact
Status	Completed
Phase	N/A
Start date	March 22, 2022
Completion date	October 19, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms