Effects of Antioxidant Dentifrice on Gingivitis

Phase 3

Completed

• Conditions: Gingivitis
• Interventions: Drug: Control toothpaste; Drug: Experimental toothpaste

• Registration Number: NCT02102295
• Lead Sponsor: Lion Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2014-03
• Study First Submitted: 2014-03-23
• Study First Submitted QC: 2014-03-29
• Last Update Submitted: 2014-03-29
• Study First Posted: 2014-04-02
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control toothpaste	Control toothpaste	fluoride
Experimental toothpaste	Experimental toothpaste	L-ascorbic acid 2-phosphate magnesium salt / fluoride

Primary Outcome Measures

Name	Time	Method
Gingival Index	3 months

Secondary Outcome Measures

Name	Time	Method
Gingivitis Severity Inedex	3 months
Gingival Redness	3 months	Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.

Trial Locations

Locations (4)

Tohoku University Dental Hospital; 🇯🇵 Sendai, Miyagi, Japan

Nihon University Hospital, School of Dentistry at Matsudo; 🇯🇵 Matsudo, Chiba, Japan

Osaka University Dental Hospital; 🇯🇵 Suita, Osaka, Japan

Nihon University Dental Hospital; 🇯🇵 Chiyoda-ku, Tokyo, Japan