Periodontal DiseasesNCT03196648
Randomized Trial of a Gum Health Formulation
A study testing Gingival health formulation in an accelerating device, Gingival health formulation on a toothbrush and OTC fluoride toothpaste in people with Periodontal Diseases and Gingivitis, run by Glo Science, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device), compared to standard tooth brushing with antioxidant whitening toothpaste with or without… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Periodontal Diseases, Gingivitis, Periodontitis
- What is being tested?
- Gingival health formulation in an accelerating device, Gingival health formulation on a toothbrush and OTC fluoride toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 30 Nov 2016
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to read, understand and sign an Informed Consent Form
- Good general health as evidenced by the medical history
- Between 18 and 55 years of age
- Male or female
- Minimum of 20 teeth, excluding crowns and third molar teeth
- Mean whole mouth Gingival Index >/=2.0 at baseline; sites with </=7mm pocket depth
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- Willing to abstain from all oral hygiene procedures 12-18 hours prior to clinical visits
- Willing to abstain from eating and drinking for 2 hours prior to clinical visits, only drinking water is allowed
- Willing to abstain from chewing gums, oral whitening products, mouthwashes and tobacco products for the study duration
- Able to understand and follow study directions
Who cannot join
- Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta-blockers
- Diagnosed with diabetes
- Presence of orthodontic appliances
- Presence of large restorations, crown or veneer at the anterior of both upper and lower teeth (including premolar teeth)
- A soft or hard tissue tumor of the oral cavity
- Carious lesions requiring immediate treatment
Show all 15Show fewer
- Patients with severe internal (tetracycline stains) and external discoloration (fluorosis)
- Patients with severe chronic periodontitis, aggressive periodontitis, acute necrotizing ulcerative gingivitis, or generalized gingival recession >2mm as evidenced by clinical oral exam
- Pregnant or breast-feeding women
- Allergy to home bleaching products such as hydrogen peroxide and carbide peroxide
- Use of antibiotics within 3 months of enrollment
- History of drug use that is associated with gum overgrowth (i.e., Dilantin, nifedipine, etc.)
- Chronic use of medication such as steroids, anti-coagulant medications, immunosuppressant medication or any other medications or medical conditions that in the opinion of the Investigator would interfere with the evaluation or confound interpretation of the study results. Use of low dose of ASA (<325mg) is permitted.
- Medical condition which requires pre-medication prior to dental visits/procedures
- Current smoking and former smoking within one year of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
The Forsyth Institute
Cambridge, Massachusetts, 02142
About this study
Official title: A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Gingival Inflammation, Oral Malodor and Tooth Whitening
The purpose of this study is to evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device), compared to standard tooth brushing with antioxidant whitening toothpaste with or without flossing (split mouth design for control group).
This is a 60-day randomized single blinded parallel group study. After 42 days, all use of interventional products were discontinued, and the participants returned to the clinical center at day 60 for final measurements. The primary outcomes assessed in this study were the differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 \& 60 days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque amount.
It is hypothesized that participants using the gingival health product with the GLO Device will experience greater reductions in GI \& BOP measurements than the control group, as well as participants using the gingival health product on a toothbrush alone.
- Conditions
- Periodontal Diseases, Gingivitis, Periodontitis, Halitosis
- Being tested
- Gingival health formulation in an accelerating device, Gingival health formulation on a toothbrush, OTC fluoride toothpaste
- Keywords
- Gingivitis, Periodontal disease, Inflammation, Teeth whitening, Breath freshening, Periodontal pathogens, Bleeding on probing
- Medical subject headings
- Periodontal Diseases, Gingivitis, Periodontitis, Halitosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival health formulation in an accelerating deviceOther
Also called ECO Balance, GLO Science accelerating device
The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used with the GLO Science Device
Gingival health formulation on a toothbrushOther
Also called ECO Balance
The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used on a toothbrush together with toothpaste.
OTC fluoride toothpasteOther
Also called GLO Science Antioxidant Toothpaste
OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.
| Study group | Role | What they receive |
|---|---|---|
| Gingival health formulation in accelerating device | Experimental | The interventional gingival health formulation is applied to the participant's mouth by means of an intra-oral accelerating device for a single eight-minute application, daily. Participants were instructed to brush their teeth with an OTC toothpaste twice daily, morning and night. Receives: Other: Gingival health formulation in an accelerating device; Other: OTC fluoride toothpaste |
| Gingival health formulation on a toothbrush | Experimental | The interventional gingival health formulation is applied to the participant's mouth by means of a toothbrush and OTC toothpaste, together with the formulation in equal amounts, for two-minute applications twice daily, morning and night. Receives: Other: Gingival health formulation on a toothbrush; Other: OTC fluoride toothpaste |
| Control group (Split mouth design) | Active comparator | The control group did not receive the interventional gingival health formulation. Participants were instructed to brush their teeth with a toothbrush and OTC toothpaste twice daily, morning and night. In addition, participants were instructed to floss only half of their mouth daily, having the non-flossed half serve as an untreated comparative control of toothbrushing alone. Receives: Other: OTC fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in bleeding on probing
Measured: Baseline to 42 days
Differences in Gingival Index
Measured: Baseline to 42 days
Secondary outcomes (6)
Difference in Plaque Index
Measured: Baseline to 42 days
Difference in mean probing depth
Measured: Baseline to 42 days
Change in oral malodor
Chromatographic measure of volatile sulfur compounds (hydrogen sulfide, dimethyl sulfide, methyl mercaptan)
Measured: Baseline to 42 days
Change in tooth whitening
Measured: Baseline to 42 days
Change in sub-gingival bacterial profile
DNA-DNA Hybridization Checkerboard; Measurement of bacterial load
Measured: Baseline to 28 days
Change in inflammatory cytokines
Measurement of IL-1B, TNF-a, IL-6, IL-8 \& MCP-1 volume from gingival crevicular fluid samples
Measured: Baseline to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 May 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glo Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Forsyth Institute
- Responsible party
- Sponsor
- Investigators
- Hatice Hasturk, DDS, PhD, Principal investigator, The Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196648
- Sponsor's protocol ID
- GLO-002
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Gingival Inflammation, Oral Malodor and Tooth Whitening
- ClinicalTrials.gov ID
- NCT03196648
- Acronym / sponsor ID
- GLO-002
- Conditions
- Periodontal Diseases, Gingivitis, Periodontitis, Halitosis
- Keywords
- Gingivitis, Periodontal disease, Inflammation, Teeth whitening, Breath freshening, Periodontal pathogens, Bleeding on probing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Glo Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Forsyth Institute
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 23 Jun 2017 (actual)
- 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 evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device), compared to standard tooth brushing with antioxidant whitening toothpaste with or without flossing (split mouth design for control group).
This is a 60-day randomized single blinded parallel group study. After 42 days, all use of interventional products were discontinued, and the participants returned to the clinical center at day 60 for final measurements. The primary outcomes assessed in this study were the differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 \& 60 days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque amount.
It is hypothesized that participants using the gingival health product with the GLO Device will experience greater reductions in GI \& BOP measurements than the control group, as well as participants using the gingival health product on a toothbrush alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gingival health formulation in accelerating device | Experimental | Other: Gingival health formulation in an accelerating device, Other: OTC fluoride toothpasteThe interventional gingival health formulation is applied to the participant's mouth by means of an intra-oral accelerating device for a single eight-minute application, daily. Participants were instructed to brush their teeth with an OTC toothpaste twice daily, morning and night. |
| Gingival health formulation on a toothbrush | Experimental | Other: Gingival health formulation on a toothbrush, Other: OTC fluoride toothpasteThe interventional gingival health formulation is applied to the participant's mouth by means of a toothbrush and OTC toothpaste, together with the formulation in equal amounts, for two-minute applications twice daily, morning and night. |
| Control group (Split mouth design) | Active comparator | Other: OTC fluoride toothpasteThe control group did not receive the interventional gingival health formulation. Participants were instructed to brush their teeth with a toothbrush and OTC toothpaste twice daily, morning and night. In addition, participants were instructed to floss only half of their mouth daily, having the non-flossed half serve as an untreated comparative control of toothbrushing alone. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Willing and able to read, understand and sign an Informed Consent Form
- Good general health as evidenced by the medical history
- Between 18 and 55 years of age
- Male or female
- Minimum of 20 teeth, excluding crowns and third molar teeth
Key exclusion criteria (15 listed)
- Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta-blockers
- Diagnosed with diabetes
- Presence of orthodontic appliances
- Presence of large restorations, crown or veneer at the anterior of both upper and lower teeth (including premolar teeth)
- A soft or hard tissue tumor of the oral cavity
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 |
|---|---|---|
| Gingival health formulation in an accelerating deviceAlso: ECO Balance, GLO Science accelerating deviceThe intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used with the GLO Science Device | Other | Gingival health formulation in accelerating device |
| Gingival health formulation on a toothbrushAlso: ECO BalanceThe intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used on a toothbrush together with toothpaste. | Other | Gingival health formulation on a toothbrush |
| OTC fluoride toothpasteAlso: GLO Science Antioxidant ToothpasteOTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate. | Other | Control group (Split mouth design), Gingival health formulation in accelerating device, Gingival health formulation on a toothbrush |
Primary outcome
Differences in bleeding on probing
Time frame: Baseline to 42 days
Differences in Gingival Index
Time frame: Baseline to 42 days
6 secondary outcomes
Difference in Plaque Index
Time frame: Baseline to 42 days
Difference in mean probing depth
Time frame: Baseline to 42 days
Change in oral malodor
Time frame: Baseline to 42 days
Change in tooth whitening
Time frame: Baseline to 42 days
Change in sub-gingival bacterial profile
Time frame: Baseline to 28 days
Change in inflammatory cytokines
Time frame: Baseline to 28 days
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 23 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Hatice Hasturk, DDS, PhD principal investigator
The Forsyth Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival health formulation in an accelerating device, Gingival health formulation on a toothbrush and OTC fluoride toothpaste in people with Periodontal Diseases and Gingivitis, run by Glo Science, Inc. at 1 site in United States.
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 10 inclusion and 15 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 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Differences in bleeding on probing (time frame: Baseline to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2017.