Slow-release Locally Administered 0.02% Hypochlorite Formulation

Tuscan Dental Institute40 enrolled

Overview

Aim: The presence of bacterial plaque is associated with the development of periodontal inflammation. The aim of this single-blind randomized clinical study was to prospectively evaluate the efficacy of two different agents in a staged approach for nonsurgical periodontal treatment in terms of clinical and patients related outcomes in a cohort of patients with periodontitis: NitrAdine® based disinfectant formula (PerioTabs®) vs Chlorhexidine 0.12 toothpaste and mouthwash 0.20. Material and methods: Patients with a diagnosis of periodontal disease (stage I-III) scheduled for non surgical periodontal treatment were randomly allocated to the preparatory home use of a chlorhexidine mouthwash or a NitrAdine® based brushing solution called PerioTabs® for 10-15 days. Active decontamination with ultrasonic scalers was performed after the completion of the preparation period. Clinical and patient-related outcomes were recorded at baseline, at the moment of professional intervention, and after 30 and 90 days from baseline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Periodontal Diseases

Interventions

PerioTabs® contains a non-antibiotic biofilm removal complex called NitrAdine®.Its anti-biofilm action is based on the combination of surfactant-induced protein denaturation and slow release of a non-toxic concentration of hypochlorite (0.02%).

Chlorhexidine 0.12 %COMBINATION_PRODUCT

chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * older than 18 y.o, * systemically healthy, * with a clinical diagnosis of periodontitis Exclusion Criteria: * alcohol or drug abuse, * regular drug use of bisphosphonates, * non-steroidal or steroidal anti-inflammatory, * daily antacid therapy, * selective serotonin reuptake inhibitors and other therapy that might affect periodontal health, * antibiotics during the previous 6 months, * smoking more than ten cigarettes per day; * pregnancy; * lactation; * previous periodontitis treatment within the last 6 months, * radiotherapy to the head or neck, current chemotherapy.

Locations (1)

Fortis Centro Odontoiatrico

Forte dei Marmi, Lucca, Italy

Outcomes

Primary Outcomes

change in full mouth bleeding score (ΔFMBS)

Time frame: Between baseline and the active debridement which occurred 15 days later

Data from ClinicalTrials.gov

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