Clinical trial NCT05254288: In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease
Official title: Evaluation of a New In-office and Domiciliary Ozonized Gel for the Management of Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: ozone
chlorhexidine
split-mouth
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in R - Gingival recession
timeFrame: Time Frame: baseline, 1, 3 and 6 months after baseline
measure: Change in PPD - Probing Pocket Depth
timeFrame: Time Frame: baseline, 1, 3 and 6 months after baseline
measure: Change in Bleeding on Probing (BOP%)
timeFrame: Time Frame: baseline, 1, 3 and 6 months after baseline
measure: Change in Plaque Control Record (PCR%)
timeFrame: Time Frame: baseline, 1, 3 and 6 months after baseline
measure: Change in Dental mobility (Miller, 1985)
timeFrame: Time Frame: baseline, 1, 3 and 6 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: