NCT02102295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
Last Updated

April 2, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

March 23, 2014

Last Update Submit

March 29, 2014

Conditions

Gingivitis

Keywords

GingivitisantioxidantdentifriceAscorbic Acid DerivativeL ascorbic acid 2 phosphate magnesium salt

Outcome Measures

Primary Outcomes (1)

  • Gingival Index

    3 months

Secondary Outcomes (2)

  • Gingivitis Severity Inedex

    3 months

  • Gingival Redness

    3 months

Other Outcomes (1)

  • salivary antioxidant status

    3 months

Study Arms (2)

Experimental toothpaste

ACTIVE COMPARATOR

L-ascorbic acid 2-phosphate magnesium salt / fluoride

Drug: Experimental toothpaste

Control toothpaste

PLACEBO COMPARATOR

fluoride

Drug: Control toothpaste

Interventions

Experimental toothpasteDRUG

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
Experimental toothpaste
Control toothpasteDRUG

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
Control toothpaste

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nihon University Hospital, School of Dentistry at Matsudo

Matsudo, Chiba, 271-8587, Japan

Location

Tohoku University Dental Hospital

Sendai, Miyagi, 980-8575, Japan

Location

Osaka University Dental Hospital

Suita, Osaka, 565-0871, Japan

Location

Nihon University Dental Hospital

Chiyoda-ku, Tokyo, 101-8310, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25277459DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Shinya Murakami

    Osaka University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2014

First Posted

April 2, 2014

Study Start

September 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 2, 2014

Record last verified: 2014-03

Locations

JP(4)