Effects of Antioxidant Dentifrice on Gingivitis

Gingivitis Clinical Trial

Official title:

Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102295
• Other study ID #: LionSDP-6
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2014
• Last updated: March 29, 2014
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: March 2014
• Source: Lion Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Experimental toothpaste
Experimental toothpaste was containing 0.3% L-ascorbic acid 2-phosphate magnesium salt and 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
• Control toothpaste
Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.

Locations

Country	Name	City	State
Japan	Nihon University Dental Hospital	Chiyoda-ku	Tokyo
Japan	Nihon University Hospital, School of Dentistry at Matsudo	Matsudo	Chiba
Japan	Tohoku University Dental Hospital	Sendai	Miyagi
Japan	Osaka University Dental Hospital	Suita	Osaka

Sponsors (4)

Lead Sponsor	Collaborator
Lion Corporation	Nihon University, Osaka University, Tohoku University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	salivary antioxidant status	Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).	3 months	No
Primary	Gingival Index		3 months	No
Secondary	Gingivitis Severity Inedex		3 months	No
Secondary	Gingival Redness	Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.	3 months	No