Slow-release Locally Administered 0.02% Hypochlorite Formulation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05846139

Enrollment

Registered

2023-05-06

Start date

2022-01-17

Completion date

2022-11-21

Last updated

2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

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.

Interventions

COMBINATION_PRODUCTPerioTabs® 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%).

COMBINATION_PRODUCTChlorhexidine 0.12 %

chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026