CClinicalTrials.gg
Sign In
CompletedNCT02102295Updated Apr 2, 2014

Effects of Antioxidant Dentifrice on Gingivitis

A Phase 3 interventional study of Experimental toothpaste and Control toothpaste in Gingivitis, sponsored by Lion Corporation. Completed at 4 sites in Japan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-02.

Sponsored by Lion Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gingivitis

Browse trials for

Keywords

  • Gingivitis
  • antioxidant
  • dentifrice
  • Ascorbic Acid Derivative
  • L ascorbic acid 2 phosphate magnesium salt
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 300 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

This is the only study on the registry with Lion Corporation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    Experimental toothpaste

    L-ascorbic acid 2-phosphate magnesium salt / fluoride

    Drug: Experimental toothpaste

  • Placebo comparator
    Control toothpaste

    fluoride

    Drug: Control toothpaste

Interventions

  • DrugExperimental 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.

    Also known as: L-ascorbic acid 2-phosphate magnesium salt toothpaste

  • DrugControl toothpaste

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

    Also known as: Fluoride toothpaste

06

What researchers measure

Primary outcomes

  1. Gingival Index

    Time frame: 3 months

Secondary outcomes

  1. Gingivitis Severity Inedex

    Time frame: 3 months

  2. Gingival Redness

    Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.

    Time frame: 3 months

Other outcomes

  1. salivary antioxidant status

    Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).

    Time frame: 3 months

07

Study locations

4 sites
  • Nihon University Hospital, School of Dentistry at Matsudo
    Matsudo, Chiba 271-8587, Japan
  • Tohoku University Dental Hospital
    Sendai, Miyagi 980-8575, Japan
  • Osaka University Dental Hospital
    Suita, Osaka 565-0871, Japan
  • Nihon University Dental Hospital
    Chiyoda-ku, Tokyo 101-8310, Japan
08

References and documents

Publications

  • 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. PubMed 25277459 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02102295
Lead sponsor
Lion Corporation
Collaborators
Osaka University, Tohoku University, Nihon University
Responsible party
Sponsor
First posted
Apr 2, 2014
Start date
Sep 2006
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Apr 2, 2014

Study contacts

Shinya Murakami
principal investigator · Osaka University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Gingivitis→

Start the discussion