Slow-release Locally Administered 0.02% Hypochlorite Formulation

NCT ID: NCT05846139

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2022-11-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PerioTabs® brushing solution

Intervention Type: COMBINATION_PRODUCT

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 0.2% 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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine 0.12 %

Intervention Type: COMBINATION_PRODUCT

chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse

Interventions

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%).

Intervention Type: COMBINATION_PRODUCT

Chlorhexidine 0.12 %

chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tuscan Dental Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fortis Centro Odontoiatrico

Forte dei Marmi, Lucca, Italy

Countries

Italy

Other Identifiers

0.02% hypochlorite formulation

Identifier Type: -

Identifier Source: org_study_id