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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254288
• Other study ID #: 2022-OZORALPAROD
• Status: Completed
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: October 19, 2022

Study information

• Verified date: October 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 19, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Other:
• Chlorhexidine
In-office and domiciliary use of chlorhexidine for 14 days.
• Ozoral gels
In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Bleeding on Probing (BOP%)	Dichotomous scoring (yes/no) of bleeding sites	Time Frame: baseline, 1, 3 and 6 months after baseline
Primary	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
Primary	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