Effects of Antioxidant Dentifrice on Gingivitis
Information source: Lion Corporation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gingivitis
Intervention: Experimental toothpaste (Drug); Control toothpaste (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Lion Corporation Official(s) and/or principal investigator(s): Shinya Murakami, Principal Investigator, Affiliation: Osaka University
Summary
The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic
acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival
redness.
Clinical Details
Official title: Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Gingival Index
Secondary outcome: Gingivitis Severity InedexGingival Redness
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age between ≥ 20 and < 65 y with at least 16 permanent teeth.
- Gingival inflammation or mean baseline GI ≥ 0. 5 without severe periodontal disease
enough to require professional therapy.
- Written informed consent to participate.
Exclusion Criteria:
- Taking medications that could influence periodontal tissue health, such as
antimicrobials and antihypertensives within 1 month before starting the trial.
- Use of orthodontic appliances.
- Pregnancy or planning to become pregnant during the trial period.
- Previous participation in any other clinical trial.
- Inability of patient to understand the study purpose and/or study protocols.
- Judged unsuitable by investigators for other reasons.
Locations and Contacts
Nihon University Hospital, School of Dentistry at Matsudo, Matsudo, Chiba 271-8587, Japan
Tohoku University Dental Hospital, Sendai, Miyagi 980-8575, Japan
Osaka University Dental Hospital, Suita, Osaka 565-0871, Japan
Nihon University Dental Hospital, Chiyoda-ku, Tokyo 101-8310, Japan
Additional Information
Starting date: September 2006
Last updated: March 29, 2014
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