NCT05846139

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Tuscan Dental Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PerioTabs® brushing solution	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%).
COMBINATION_PRODUCT	Chlorhexidine 0.12 %	chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2023-05-06
• Last updated: 2023-05-06

Locations

1 site across 1 country: Italy