Slow-release Locally Administered 0.02% Hypochlorite Formulation

Tuscan Dental Institute

Status: Completed

Conditions: Periodontal Diseases

Treatments: Combination Product: PerioTabs® brushing solution; Combination Product: Chlorhexidine 0.12 %

Study type: Interventional

Funder types: Other

Identifiers

NCT05846139

0.02% hypochlorite formulation

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

PerioTabs® brushing solution

Experimental group

Description:

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.

Treatment:

Combination Product: PerioTabs® brushing solution

Chlorhexidine 0.2% mouth rinse

Active Comparator group

Description:

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.

Treatment:

Combination Product: Chlorhexidine 0.12 %