Slow-release Locally Administered 0.02% Hypochlorite Formulation

NCT05846139 | Completed

• 1 other identifier: 0.02% hypochlorite formulation
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• change in full mouth bleeding score (ΔFMBS)

  Between baseline and the active debridement which occurred 15 days later

Study Arms (2)

PerioTabs® brushing solution

EXPERIMENTAL

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

Chlorhexidine 0.2% mouth rinse

ACTIVE COMPARATOR

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 %

Interventions

PerioTabs® brushing solution 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%).

PerioTabs® brushing solution

Chlorhexidine 0.12 % COMBINATION_PRODUCT

chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse

Chlorhexidine 0.2% mouth rinse

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 y.o,
• systemically healthy,
• with a clinical diagnosis of periodontitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tuscan Dental Institute: lead

Study Sites (1)

Fortis Centro Odontoiatrico

Forte dei Marmi, Lucca, 55042, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: May 6, 2023
• Study Start: January 17, 2022
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

IT (1)