Skip to content

A Pilot study of periodontopathic Bacterial Load suppression Efficacy Assessment of biofilm Cleaning in Healthy volunteers and patients with mild periodontitis

A Pilot study of periodontopathic Bacterial Load suppression Efficacy Assessment of biofilm Cleaning in Healthy volunteers and patients with mild periodontitis - P-BLEACH study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050521
Enrollment
10
Registered
2023-03-07
Start date
2023-03-07
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Healthy individuals

Interventions

Dental treatment (Professional Mechanical Tooth Cleaning / PMTC) is performed to healthy individuals.

Sponsors

Aichi gakuin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy individuals who meet all of the following criteria are included in this study; <Inclusion criteria for provisional registration> 1. Male or female aged 30 year or older and 65 year or younger 2. Individuals who generally take meals three times per day 3. Individuals in whom labial and buccal surfaces of at least 4 teeth among the following teeth are measurable; FDI tooth number 16 (maxillary right first molar, 21 (maxillary left central incisor), 36 (mandibular left first molar), 41 (mandibular right central incisor), 44 (mandibular right first premolar) or healthy individuals who have the following teeth in place of the 6 teeth mentioned above; FDI tooth number 17, 15, 11, 22, 25, 37, 35, 31, 42, 45 4. Individuals with 20 teeth or more 5. Individuals without habit of polishing tongue at teeth brushing 6. Individuals who provide their consent to participate in this study in written form after full explanation of this study <Inclusion criteria for actual registration> 7. Individuals in whom P. gingivalis is detected at the screening test

Exclusion criteria

Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study; 1. Individuals with smoking habit 2. Individuals who are taking medical agents due to diabetes mellitus, chronic renal disease, gastrointestinal disorder, pulmonary disease, malignant tumor, etc. 3. Individuals who routinely use products that inhibit periodontopathogenic bacteria, such as mouth wash agents 4. Individuals whose stimulant saliva is 3.0mL or less

Design outcomes

Primary

MeasureTime frame
Amount and change of periodontopathogenic bacteria (P. gingivalis and F. nucleatum bacteria) in stimulated saliva measured by PCR invader method

Secondary

MeasureTime frame
Measurement at each observation point and change from baseline to each observation point of following items; 1. Amount of periodontopathogenic bacteria (P. gingivalis and F. nucleatum bacteria) in stimulated saliva measured by PMA-qPCR method 2. Amount of other bacteria (Campylobacter concisus) in stimulated saliva 3. Characteristics of stimulated saliva (pH, amount) 4. Concentration of calprotectin in stimulated saliva 5. Concentration of vascular endothelial growth factor (VEGF) and human epidermal growth factor (hEGF) in stimulated saliva 6. clinical indicators (gingival index (GI), plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinincal attachment level (CAL), and tongue coating score)

Countries

Japan

Contacts

Public ContactHiroki Takayama

Soiken, Inc. Clinical Study Support Division

takayama@soiken.com03-3295-1350

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026