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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split-mouth Group A | Experimental | Half of patients will be assigned to this group. Quadrants Q1/Q4 will receive ozone administration. Quadrants Q2/Q3 will receive chlorhexidine administration. |
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| Split-mouth Group B | Experimental | Half of patients will be assigned to this group Quadrants Q2/Q3 will receive ozone administration. Quadrants Q1/Q4 will receive chlorhexidine administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Other | In-office and domiciliary use of chlorhexidine for 14 days. |
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| 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
| Time Frame: baseline, 1, 3 and 6 months after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD, MS | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to Principal Investigator.
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Split-mouth
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Gels concealed
| Ozoral gels | Other | In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days. |
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