Slow-release Locally Administered 0.02% Hypochlorite Formulation

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Combination Product: PerioTabs® brushing solution; Combination Product: Chlorhexidine 0.12 %

• Registration Number: NCT05846139
• Lead Sponsor: Tuscan Dental Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-17
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Status Verified: 2023-04
• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PerioTabs® brushing solution	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.
Chlorhexidine 0.2% mouth rinse	Chlorhexidine 0.12 %	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.

Primary Outcome Measures

Name	Time	Method
change in full mouth bleeding score (ΔFMBS)	Between baseline and the active debridement which occurred 15 days later

Trial Locations

Locations (1)

Fortis Centro Odontoiatrico; 🇮🇹 Forte Dei Marmi, Lucca, Italy