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

University of Pavia

Status: Completed

Conditions: Periodontal Diseases

Treatments: Other: Chlorhexidine; Other: Ozoral gels

Study type: Interventional

Funder types: Other

Identifiers

NCT05254288

2022-OZORALPAROD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of bilateral periodontal sites according to the new Classification of Periodontal and Peri-implant Diseases (Severity: Staging I; Complexity: Staging II).
• No systemic disease;
• Compliant patients.

Exclusion criteria

• Absence of dental implants;
• Neurological and psychiatric diseases;
• Patients taking bisphosphonates during the previous 12 months from the beginning of the study;
• Pregnant and/or breastfeeding women;
• Patients undergoing anticancer therapy.
• Patients with poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups

Split-mouth Group A

Experimental group

Description:

Half of patients will be assigned to this group. Quadrants Q1/Q4 will receive ozone administration. Quadrants Q2/Q3 will receive chlorhexidine administration.

Treatment:

Other: Chlorhexidine

Other: Ozoral gels

Split-mouth Group B

Experimental group

Description:

Half of patients will be assigned to this group Quadrants Q2/Q3 will receive ozone administration. Quadrants Q1/Q4 will receive chlorhexidine administration.

Treatment:

Other: Chlorhexidine

Other: Ozoral gels