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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 Inedex

Gingival 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

Page last updated: August 20, 2015

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