- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02102295
Effects of Antioxidant Dentifrice on Gingivitis
March 29, 2014 updated by: Lion Corporation
Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chiba
-
Matsudo, Chiba, Japan, 271-8587
- Nihon University Hospital, School of Dentistry at Matsudo
-
-
Miyagi
-
Sendai, Miyagi, Japan, 980-8575
- Tohoku University Dental Hospital
-
-
Osaka
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Suita, Osaka, Japan, 565-0871
- Osaka University Dental Hospital
-
-
Tokyo
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Chiyoda-ku, Tokyo, Japan, 101-8310
- Nihon University Dental Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Experimental toothpaste
L-ascorbic acid 2-phosphate magnesium salt / fluoride
|
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:
|
PLACEBO_COMPARATOR: Control toothpaste
fluoride
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gingival Index
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gingivitis Severity Inedex
Time Frame: 3 months
|
3 months
|
|
Gingival Redness
Time Frame: 3 months
|
Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
salivary antioxidant status
Time Frame: 3 months
|
Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shinya Murakami, Osaka University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (ACTUAL)
July 1, 2007
Study Completion (ACTUAL)
July 1, 2007
Study Registration Dates
First Submitted
March 23, 2014
First Submitted That Met QC Criteria
March 29, 2014
First Posted (ESTIMATE)
April 2, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
April 2, 2014
Last Update Submitted That Met QC Criteria
March 29, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Gingival Diseases
- Gingivitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Cariostatic Agents
- Fluorides
- Ascorbic Acid
- Ascorbate-2-phosphate
Other Study ID Numbers
- LionSDP-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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