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Effects of Antioxidant Dentifrice on Gingivitis

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ClinicalTrials.gov Identifier: NCT02102295
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Collaborators:
Osaka University
Tohoku University
Nihon University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gingivitis Drug: Experimental toothpaste Drug: Control toothpaste Phase 3

Study Type : Interventional  (Clinical Trial)
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 : September 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Fluoride toothpaste




Primary Outcome Measures :
  1. Gingival Index [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Gingivitis Severity Inedex [ Time Frame: 3 months ]
  2. Gingival Redness [ Time Frame: 3 months ]
    Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.


Other Outcome Measures:
  1. salivary antioxidant status [ Time Frame: 3 months ]
    Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102295


Locations
Japan
Nihon University Hospital, School of Dentistry at Matsudo
Matsudo, Chiba, Japan, 271-8587
Tohoku University Dental Hospital
Sendai, Miyagi, Japan, 980-8575
Osaka University Dental Hospital
Suita, Osaka, Japan, 565-0871
Nihon University Dental Hospital
Chiyoda-ku, Tokyo, Japan, 101-8310
Sponsors and Collaborators
Lion Corporation
Osaka University
Tohoku University
Nihon University
Investigators
Principal Investigator: Shinya Murakami Osaka University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lion Corporation
ClinicalTrials.gov Identifier: NCT02102295     History of Changes
Other Study ID Numbers: LionSDP-6
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: March 2014

Keywords provided by Lion Corporation:
Gingivitis
antioxidant
dentifrice
Ascorbic Acid Derivative
L ascorbic acid 2 phosphate magnesium salt

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Ascorbic Acid
Antioxidants
Ascorbate-2-phosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Vitamins
Micronutrients
Growth Substances
Antineoplastic Agents