Slow-release Locally Administered 0.02% Hypochlorite Formulation

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of an Incremental Approach to Nonsurgical Periodontal Therapy With the Use of Adjunctive Slow-release Locally Administered 0.02% Hypochlorite Formulation: A Single-blind Randomized Clinical Study

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Combination Product: PerioTabs® brushing solution
* Combination Product: Chlorhexidine 0.12 %


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PerioTabs® brushing solution<br>At baseline, patients were given instructions for the home use of PerioTabs® for daily gum and toothbrushing for 10 consecutive days, according to the product's directions for use. The procedure consisted of brushing the teeth and gums for 2 minutes in the evening during a 10-day period. After one week, one-stage full-mouth disinfection was performed with the use of ultrasonic devices on each quadrant. In addition, two cycles of 90 seconds ozone-therapy were carried out. | Combination Product: PerioTabs® brushing solution<br>* 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%).<br>|
| Active Comparator: Chlorhexidine 0.2% mouth rinse<br>At baseline, patients were given instructions for the home use of toothbrush with chlorhexidine 0.12 % toothpaste for 15 days toothbrushing twice daily (morning and evening). Also, a chlorhexidine 0.2% mouth rinse had to be used every evening for the course of the 15 days. After two weeks, the one-stage full-mouth disinfection was performed in the same way as in Group 1. | Combination Product: Chlorhexidine 0.12 %<br>* chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in full mouth bleeding score (ΔFMBS) |  | Between baseline and the active debridement which occurred 15 days later |