In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: Chlorhexidine
In-office and domiciliary use of chlorhexidine for 14 days.
Other: Ozoral gels
In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.
|
| Experimental: 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. |
Other: Chlorhexidine
In-office and domiciliary use of chlorhexidine for 14 days.
Other: Ozoral gels
In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.
|
Outcome Measures
Primary Outcome Measures
- Change in R - Gingival recession [Time Frame: baseline, 1, 3 and 6 months after baseline]
Distance (in mm) between the gingival margin and the amelo-cemental junction.
- Change in PPD - Probing Pocket Depth [Time Frame: baseline, 1, 3 and 6 months after baseline]
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.
- Change in Bleeding on Probing (BOP%) [Time Frame: baseline, 1, 3 and 6 months after baseline]
Dichotomous scoring (yes/no) of bleeding sites
- Change in Plaque Control Record (PCR%) [Time Frame: baseline, 1, 3 and 6 months after baseline]
% 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.
- Change in Dental mobility (Miller, 1985) [Time Frame: baseline, 1, 3 and 6 months after baseline]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Presence of bilateral periodontal sites according to the new Classification of Periodontal and Peri-implant Diseases (Severity: Staging I; Complexity: Staging II).
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No systemic disease;
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Compliant patients.
Exclusion Criteria:
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Absence of dental implants;
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Neurological and psychiatric diseases;
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Patients taking bisphosphonates during the previous 12 months from the beginning of the study;
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Pregnant and/or breastfeeding women;
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Patients undergoing anticancer therapy.
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Patients with poor compliance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | Italy | 27100 |
Sponsors and Collaborators
- University of Pavia
Investigators
- Principal Investigator: Andrea Scribante, DDS, PhD, MS, University of Pavia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-OZORALPAROD