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

  • Japan
    • 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
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Dental Hospital
    • Tokyo
      • 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
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

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

Lion Corporation

Collaborators

Osaka University
Nihon University
Tohoku University

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.

General Publications

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

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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