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Effects of Antioxidant Dentifrice on Gingivitis

Primary Purpose

Gingivitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Experimental toothpaste
Control toothpaste
Sponsored by
Lion Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis, antioxidant, dentifrice, Ascorbic Acid Derivative, L ascorbic acid 2 phosphate magnesium salt

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nihon University Hospital, School of Dentistry at Matsudo
  • Tohoku University Dental Hospital
  • Osaka University Dental Hospital
  • Nihon University Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental toothpaste

Control toothpaste

Arm Description

L-ascorbic acid 2-phosphate magnesium salt / fluoride

fluoride

Outcomes

Primary Outcome Measures

Gingival Index

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2014
Last Updated
March 29, 2014
Sponsor
Lion Corporation
Collaborators
Osaka University, Tohoku University, Nihon University
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1. Study Identification

Unique Protocol Identification Number
NCT02102295
Brief Title
Effects of Antioxidant Dentifrice on Gingivitis
Official Title
Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lion Corporation
Collaborators
Osaka University, Tohoku University, Nihon University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Gingivitis, antioxidant, dentifrice, Ascorbic Acid Derivative, L ascorbic acid 2 phosphate magnesium salt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental toothpaste
Arm Type
Active Comparator
Arm Description
L-ascorbic acid 2-phosphate magnesium salt / fluoride
Arm Title
Control toothpaste
Arm Type
Placebo Comparator
Arm Description
fluoride
Intervention Type
Drug
Intervention Name(s)
Experimental toothpaste
Other Intervention Name(s)
L-ascorbic acid 2-phosphate magnesium salt toothpaste
Intervention Description
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
Intervention Name(s)
Control toothpaste
Other Intervention Name(s)
Fluoride toothpaste
Intervention Description
Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
Primary Outcome Measure Information:
Title
Gingival Index
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Gingivitis Severity Inedex
Time Frame
3 months
Title
Gingival Redness
Description
Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
salivary antioxidant status
Description
Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinya Murakami
Organizational Affiliation
Osaka University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nihon University Hospital, School of Dentistry at Matsudo
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
271-8587
Country
Japan
Facility Name
Tohoku University Dental Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8575
Country
Japan
Facility Name
Osaka University Dental Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Nihon University Dental Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8310
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25277459
Citation
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.
Results Reference
derived

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Effects of Antioxidant Dentifrice on Gingivitis

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