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Use of PerioTabsTM for patients with gingivitis

Evaluating the clinical efficiency of PerioTabsTM, a new home-care based oral hygiene approach, for patients suffering from gingivitis: a prospective open-label single-arm pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14006811
Enrollment
30
Registered
2020-12-01
Start date
2018-06-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Gingivitis Oral Health Gingivitis and periodontal diseases

Interventions

This is a prospective, open-label study, that involves giving a specific preparation (a non-antibiotic biofilm removal formulation based on NitrAdineTM) to a cohort of subjects with diagnosed gingivit
while the tablet is dissolving, the toothbrush is immersed in the solution and left for 15 minutes, the time required for the tablet to completely dissolve. Patients then brush their teeth and gums (i

Sponsors

University of Turin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged = 18 2. Gingivitis diagnosis 3. No detectable oral mucosal lesions 4. Able to complete the present clinical trial

Exclusion criteria

Exclusion criteria: 1. Unable or unwilling to provide informed consent 2. Significant psychiatric or cognitive impairment 3. Pregnant or breast-feeding women 4. Subjects with an history of allergy for ingredients present in PerioTabsTM 5. Subjects with carious teeth 6. Subjects affected by periodontitis or suffering from oral acute conditions requiring antibiotics

Design outcomes

Primary

MeasureTime frame
1. Gingival inflammation measured using Gingival Index (bleeding on probing) at baseline at 10 days and 36 weeks 2. Plaque formation measured using Plaque Index (PI) at baseline at 10 days and 36 weeks

Secondary

MeasureTime frame
1. Reported adverse events due to the treatment assessed from patient notes at the end of the study 2. Unexpected effects assessed from patient diary records collected at the end of the study

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026