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

NCT ID: NCT05254288

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2022-10-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Split-mouth Group A

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

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: OTHER

In-office and domiciliary use of chlorhexidine for 14 days.

Ozoral gels

Intervention Type: OTHER

In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.

Split-mouth Group B

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

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: OTHER

In-office and domiciliary use of chlorhexidine for 14 days.

Ozoral gels

Intervention Type: OTHER

In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.

Interventions

Chlorhexidine

In-office and domiciliary use of chlorhexidine for 14 days.

Intervention Type: OTHER

Ozoral gels

In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, DDS, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Countries

Italy

Other Identifiers

2022-OZORALPAROD

Identifier Type: -

Identifier Source: org_study_id