Effects of Antioxidant Dentifrice on Gingivitis

Sponsor

Lion Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT02102295

Collaborator

Osaka University (Other), Tohoku University (Other), Nihon University (Other)

300

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Drug: Experimental toothpaste Drug: Control toothpaste	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Experimental toothpaste L-ascorbic acid 2-phosphate magnesium salt / fluoride	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. Other Names: L-ascorbic acid 2-phosphate magnesium salt toothpaste
Placebo Comparator: Control toothpaste fluoride	Drug: 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. Other Names: Fluoride toothpaste

Arm

Intervention/Treatment

Active Comparator: Experimental toothpaste

L-ascorbic acid 2-phosphate magnesium salt / fluoride

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.

Other Names:

L-ascorbic acid 2-phosphate magnesium salt toothpaste

Placebo Comparator: Control toothpaste

fluoride

Drug: 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.

Other Names:

Fluoride toothpaste

Outcome Measures

Primary Outcome Measures

Gingival Index [3 months]

Secondary Outcome Measures

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.

Other Outcome Measures

salivary antioxidant status [3 months]
Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nihon University Hospital, School of Dentistry at Matsudo	Matsudo	Chiba	Japan	271-8587
2	Tohoku University Dental Hospital	Sendai	Miyagi	Japan	980-8575
3	Osaka University Dental Hospital	Suita	Osaka	Japan	565-0871
4	Nihon University Dental Hospital	Chiyoda-ku	Tokyo	Japan	101-8310