Slow-release Locally Administered 0.02% Hypochlorite Formulation
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lucca
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Forte Dei Marmi, Lucca, Italy, 55042
- Fortis Centro Odontoiatrico
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PerioTabs® brushing solution
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.
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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%).
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Active Comparator: Chlorhexidine 0.2% mouth rinse
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.
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chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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change in full mouth bleeding score (ΔFMBS)
Time Frame: Between baseline and the active debridement which occurred 15 days later
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Between baseline and the active debridement which occurred 15 days later
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0.02% hypochlorite formulation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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