Slow-release Locally Administered 0.02% Hypochlorite Formulation

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05846139
• Other study ID #: 0.02% hypochlorite formulation
• Status: Completed
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: November 21, 2022

Study information

• Verified date: April 2023
• Source: Tuscan Dental Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

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%).
• Chlorhexidine 0.12 %
chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse

Locations

Country	Name	City	State
Italy	Fortis Centro Odontoiatrico	Forte Dei Marmi	Lucca

Sponsors (1)

Lead Sponsor	Collaborator
Tuscan Dental Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in full mouth bleeding score (?FMBS)		Between baseline and the active debridement which occurred 15 days later