A multi-center randomized controlled clinical trial to examine the clinical, biochemical and antimicrobial effects of a mouth rinse on patients with mild periodontal disease.

A multi-center randomized controlled clinical trial to examine the clinical, biochemical and antimicrobial effects of a mouth rinse on patients with mild periodontal disease. - A multi-center clinical trial to examine the effects of a mouth rinse on patients with mild periodontal disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006407

Enrollment

Registered

2011-12-01

Start date

2011-12-01

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

mild periodontal disease

Interventions

Test group First of all, subjects are instructed to brush their teeth as usual twice a day (in the morning and in the evening) with the supplied dentifrice containing sodium fluoride and toothbrush.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) 20 years old or older persons who obtained written informed consent. (2) Persons who have good general health with 20 teeth or more. (3) Persons who have no plan to receive dental treatment during this study period. (4) Persons who have greater than or equal to 1.5 in QHI (Quigley-Hein Plaque Index) score. (5) Persons who have greater than or equal to 1.0 and less than 2.3 in MGI (Modified Gingival Index) score.

Exclusion criteria

Exclusion criteria: (1) Persons who took antibiotics and anti-inflammatory agent (except external use) for the past one month prior to this study. (2) Persons who use a dental floss or an interdental brush daily. (3) Persons who have the medical history of hypersensitivity to the ingredients (cetylpyridinium chloride, triclosan, dipotassium glycyrrhizinate and others.) containing the mouth rinse. (4) Persons who are suspected to be diabetic or pregnant. (5) Persons who have five or more untreated caries lesions (scored C2 and up). (6) Severe periodontitis patients with tooth mobility or abscess formation. (7) Persons who are judged to be unqualified for this study subjects by investigators.

Design outcomes

Primary

Measure	Time frame
1. Quigley-Hein plaque index (QHI) 2. Modified gingival index (MGI) 3. Probing pocket depth (PD) 4. Bleeding on probing (BOP) 5. Cytokine levels in gingival crevicular fluid 6. The number of total bacteria and some periodontopathic bacteria in subgingival plaque	—

Countries

Japan

Contacts

Public ContactKaori KIMURA

Osaka University Graduate School of Dentistry Department of Periodontology, Division of Oral Biology and Disease control

kimura-k@office.osaka-u.ac.jp06-6879-2831

Outcome results

None listed

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