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Evaluation of a point-of-care test kit for the detection of periodontal pathogen in the treatment of periodontal disease: a multi-center study

Evaluation of a point-of-care test kit for the detection of periodontal pathogen in the treatment of periodontal disease: a multi-center study - Evaluation of a test kit for the detection of periodontal pathogen

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011943
Enrollment
60
Registered
2015-09-01
Start date
2013-10-03
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

Periodontal disease

Interventions

Following SRP, a microbiological assessment using a test kit is performed. Then, minocycline (Periofeel)is locally delivered to positive sites. Control (Periodontally healthy individuals)

Sponsors

Tokyo Dental College Nihon University School of Dentistry at Matsudo Tsurumi University Niigata University
Lead Sponsor
Showa Yakuhin Kako Co LTD Denka Seiken Co LTD
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Periodontitis patients with at least one site with PD 4-5 mm (mild periodontitis). 2. Periodontitis patients with at least one site with PD 6-9 mm (severe periodontitis). 3. Periodontally healthy individuals (control) 4. Those who completed full-mouth scaling before the start of the study (baseline). 5. Those who agreed to participate in the study with written informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with uncontrolled systemic diseases (ex. diabetes, hyperlipidemia, cardiovascular diseases, osteoporosis, autoimmune diseases) 2. Smokers 3. Those with aggressive periodontitis 4. History of antimicrobial treatment within 3 months 5. Those who received SRP within 6 months 6. History of allergic reaction against antimicrobials (especially tetracyclines)

Design outcomes

Primary

MeasureTime frame
1. To compare the results from a commercial test(PCR-Invader) and the present test kit in control and periodontitis groups at baseline. 2. To compare the results from a commercial test and the present test kit before and after SRP (scaling and root planing) and after the use of Periofeel.

Secondary

MeasureTime frame
The following parameters before SRP, after SRP and after the use of Periofeel. 1)Probing pocket depth 2)Bleeding on probing 3)Clinical attachment level 4)Gingival index 5)Plaque indel 6)Tooth mobility

Countries

Japan

Contacts

Public ContactToshiya Morozumi

Niigata University Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences

moro@dent.niigata-u.ac.jp025-227-2869

Outcome results

None listed

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