GingivitisPhase 3NCT02102295
Effects of Antioxidant Dentifrice on Gingivitis
A Phase 3 study testing Experimental toothpaste in people with Gingivitis, run by Lion Corporation at 4 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Experimental toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 4 sitesJapan
- Study dates
- Sep 2006to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Nihon University Dental Hospital
Chiyoda-ku, Tokyo, 101-8310
Nihon University Hospital, School of Dentistry at Matsudo
Matsudo, Chiba, 271-8587
Tohoku University Dental Hospital
Sendai, Miyagi, 980-8575
Osaka University Dental Hospital
Suita, Osaka, 565-0871
About this study
Official title: 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.
- Conditions
- Gingivitis
- Being tested
- Experimental toothpaste, Control toothpaste
- Keywords
- Gingivitis, antioxidant, dentifrice, Ascorbic Acid Derivative, L ascorbic acid 2 phosphate magnesium salt
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental toothpasteDrug
Also called L-ascorbic acid 2-phosphate magnesium salt 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.
Control toothpasteDrug
Also called Fluoride toothpaste
Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
| Study group | Role | What they receive |
|---|---|---|
| Experimental toothpaste | Active comparator | L-ascorbic acid 2-phosphate magnesium salt / fluoride Receives: Drug: Experimental toothpaste |
| Control toothpaste | Placebo comparator | fluoride Receives: Drug: Control toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index
Measured: 3 months
Secondary outcomes (2)
Gingivitis Severity Inedex
Measured: 3 months
Gingival Redness
Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startSep 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lion Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Osaka University, Tohoku University, Nihon University
- Responsible party
- Sponsor
- Investigators
- Shinya Murakami, Principal investigator, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102295
- Sponsor's protocol ID
- LionSDP-6
- Status last verified
- Mar 2014
- First submitted
- 23 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis
- ClinicalTrials.gov ID
- NCT02102295
- Acronym / sponsor ID
- LionSDP-6
- Conditions
- Gingivitis
- Keywords
- Gingivitis, antioxidant, dentifrice, Ascorbic Acid Derivative, L ascorbic acid 2 phosphate magnesium salt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Lion CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Osaka University, Tohoku University, Nihon University
- Study start
- Sep 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental toothpaste | Active comparator | Drug: Experimental toothpasteL-ascorbic acid 2-phosphate magnesium salt / fluoride |
| Control toothpaste | Placebo comparator | Drug: Control toothpastefluoride |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental toothpasteAlso: L-ascorbic acid 2-phosphate magnesium salt toothpasteExperimental 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. | Drug | Experimental toothpaste |
| Control toothpasteAlso: Fluoride toothpasteControl toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner. | Drug | Control toothpaste |
Primary outcome
Gingival Index
Time frame: 3 months
2 secondary outcomes
Gingivitis Severity Inedex
Time frame: 3 months
Gingival Redness
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Derived from this study: PubMed 25277459Shimabukuro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shinya Murakami principal investigator
Osaka University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental toothpaste in people with Gingivitis, run by Lion Corporation at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.