Effects of Antioxidant Dentifrice on Gingivitis

NCT ID: NCT02102295

Last Updated: 2014-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental toothpaste

L-ascorbic acid 2-phosphate magnesium salt / fluoride

Group Type ACTIVE_COMPARATOR

Experimental toothpaste

Intervention Type DRUG

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

fluoride

Group Type PLACEBO_COMPARATOR

Control toothpaste

Intervention Type DRUG

Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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L-ascorbic acid 2-phosphate magnesium salt toothpaste Fluoride toothpaste

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Osaka University

OTHER

Sponsor Role collaborator

Tohoku University

OTHER

Sponsor Role collaborator

Nihon University

OTHER

Sponsor Role collaborator

Lion Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shinya Murakami

Role: PRINCIPAL_INVESTIGATOR

Osaka University

Locations

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Nihon University Hospital, School of Dentistry at Matsudo

Matsudo, Chiba, Japan

Site Status

Tohoku University Dental Hospital

Sendai, Miyagi, Japan

Site Status

Osaka University Dental Hospital

Suita, Osaka, Japan

Site Status

Nihon University Dental Hospital

Chiyoda-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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Shimabukuro Y, Nakayama Y, Ogata Y, Tamazawa K, Shimauchi H, Nishida T, Ito K, Chikazawa T, Kataoka S, Murakami S. Effects of an ascorbic acid-derivative dentifrice in patients with gingivitis: a double-masked, randomized, controlled clinical trial. J Periodontol. 2015 Jan;86(1):27-35. doi: 10.1902/jop.2014.140138.

Reference Type DERIVED
PMID: 25277459 (View on PubMed)

Other Identifiers

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LionSDP-6

Identifier Type: -

Identifier Source: org_study_id

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