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

Study Overview
=================
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.

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

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Other: Chlorhexidine
* Other: Ozoral gels


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Split-mouth Group A<br>Half of patients will be assigned to this group. Quadrants Q1/Q4 will receive ozone administration. Quadrants Q2/Q3 will receive chlorhexidine administration. | Other: Chlorhexidine<br>* In-office and domiciliary use of chlorhexidine for 14 days.<br>Other: Ozoral gels<br>* In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.<br>|
| Experimental: Split-mouth Group B<br>Half of patients will be assigned to this group Quadrants Q2/Q3 will receive ozone administration. Quadrants Q1/Q4 will receive chlorhexidine administration. | Other: Chlorhexidine<br>* In-office and domiciliary use of chlorhexidine for 14 days.<br>Other: Ozoral gels<br>* In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in R - Gingival recession | Distance (in mm) between the gingival margin and the amelo-cemental junction. | Time Frame: baseline, 1, 3 and 6 months after baseline | 
| Change in PPD - Probing Pocket Depth | 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. | Time Frame: baseline, 1, 3 and 6 months after baseline | 
| Change in Bleeding on Probing (BOP%) | Dichotomous scoring (yes/no) of bleeding sites | Time Frame: baseline, 1, 3 and 6 months after baseline | 
| Change in Plaque Control Record (PCR%) | % assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage. | Time Frame: baseline, 1, 3 and 6 months after baseline | 
| Change in Dental mobility (Miller, 1985) | Scoring criteria Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; Grade II: horizontal mobility of the tooth from 1 to 2 mm; Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth. | Time Frame: baseline, 1, 3 and 6 months after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ozone, chlorhexidine, split-mouth