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OpenTrials
Completed

NCT Number: NCT05846139

Slow-release Locally Administered 0.02% Hypochlorite Formulation

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fortis Centro Odontoiatrico

Forte dei Marmi, Lucca, 55042, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%).

Chlorhexidine 0.12 %

Combination Product

chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse

Primary outcomes

  1. change in full mouth bleeding score (ΔFMBS)

    Time frame: Between baseline and the active debridement which occurred 15 days later

Sponsors and collaborators

Lead sponsor

Tuscan Dental Institute

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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