Tooth DiscolorationNCT02906982
Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
A study testing Gum health formulation in intra-oral device and Gum health formulation on toothbrush in people with Tooth Discoloration and Periodontal Diseases, run by Glo Science, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a novel gum health formulation, when used in an intra-oral device or on a toothbrush, for teeth whitening and clinical improvements in periodontal diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tooth Discoloration, Periodontal Diseases
- What is being tested?
- Gum health formulation in intra-oral device and Gum health formulation on toothbrush
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older 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 65 years of age
- A minimum of 20 teeth, excluding crowns and third molar teeth
- A mean whole mouth Gingival Index score of >2.0 at baseline
- Sites with <7mm pocket depth
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- Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits
- Willing to abstain from eating and drinking in the morning of visits, only drinking water
- Willing to abstain from chewing gums, oral whitening products, mouthwashes and tobacco products for the study duration
- Ability to understand and follow study protocol
- No known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products
Who cannot join
- Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta blockers
- Diagnosis of diabetes mellitus
- 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
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- Carious lesions
- Severe internal (tetracycline stains) and external discolouration (fluorosis)
- Diagnosis of severe chronic periodontitis, aggressive periodontitis, acute necrotizing ulcerative gingivitis or generalized gingival recession >2mm as evidenced by clinical oral exam
- Participating in another clinical trial or oral product study
- Pregnant or breast-feeding women
- Allergy to home bleaching products such as hydrogen peroxide and carbamide peroxide
- Use of antibiotics within 3 months of enrolment
- 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 medications 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
- Medical condition which requires pre-medication prior to dental visits/procedures
- Smokers
- Patients who have received quadrant or maintenance scaling \& root planing and/or periodontal surgical therapy within 6 months prior to enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
The purpose of this study is to evaluate the efficacy of a novel gum health formulation, when used in an intra-oral device or on a toothbrush, for teeth whitening and clinical improvements in periodontal diseases.
Read the detailed description
Over half of the American population suffers from some form of periodontal disease, while millions of Americans are electing for teeth whitening procedures every year. The study is designed to assess the efficacy of a novel gum health formulation on teeth whitening in the context of gingival inflammation. Further, the study aims to assess the efficacy of the novel gum health formulation as an adjunct to the current standard of care in the treatment of gingivitis and periodontitis, depending on the severity of disease. As the dental professional community is whitening teeth in an environment of gingival inflammation, a single product that whitens teeth and controls inflammation is a novel treatment approach and highly desirable among patients and consumers.
- Conditions
- Tooth Discoloration, Periodontal Diseases
- Being tested
- Gum health formulation in intra-oral device, Gum health formulation on toothbrush
- Keywords
- Periodontal diseases, Periodontitis, Gingivitis, Teeth Whitening, Dental Plaque Index, Periodontal Index, Teeth Whitening Agents, Tooth Discoloration, Mean Probing Depth, Pocket Depth
- Medical subject headings
- Tooth Discoloration, Periodontal Diseases, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum health formulation in intra-oral deviceOther
Also called ECO Balance, GLO Science intra-oral accelerating device
The intervention is a gum health formulation for periodontal disease care and teeth whitening to be used within an accelerating intra-oral device.
Gum health formulation on toothbrushOther
Also called ECO Balance
The intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Gum health formulation in intra-oral device | Experimental | The interventional gum health formulation is applied to the participant's mouth by means of an intra-oral device for a single eight-minute application, daily. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night. Receives: Other: Gum health formulation in intra-oral device |
| Gum health formulation on toothbrush | Experimental | The interventional gum health formulation is applied to the participant's mouth by means of a toothbrush and toothpaste, plus the gum health formulation, for two-minute applications, twice daily, morning and night. Receives: Other: Gum health formulation on toothbrush |
| Control group (split-mouth design) | No intervention | The control group did not receive the interventional gum health formulation. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night. In addition, participants instructed to floss only half of their mouth daily, and the non-flossed half serves as the untreated comparative control receiving no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Tooth Shade Value over 45 Days
Tooth Shade Value was measured using a Vita Shade Guide and the measurement was transformed to a standardized value.
Measured: Baseline, Day 14, Day 28, Day 45
Secondary outcomes (4)
Plaque Index
Periodontal probe will be swept along the buccal and lingual surfaces and plaque is noted.
Measured: Baseline, Day 14, Day 28, Day 45
Gingival Index
Periodontal probe will be placed under the gingival margin and swept along the buccal and lingual surfaces and bleeding is noted.
Measured: Baseline, Day 14, Day 28, Day 45
Bleeding Index
Bleeding will be assessed after probing. A dichotomous scoring system is used at six sites per tooth using one and zero for presence or absence, respectively.
Measured: Baseline, Day 14, Day 28, Day 45
Mean Probing Depth
Pocket depth will be determined with a UNC-15 periodontal probe at six sites per tooth rounded to the next lower whole millimeter.
Measured: Baseline, Day 14, Day 28, Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glo Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EEC Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- Edgard El Chaar, DDS, MS, Principal investigator, EEC Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906982
- Sponsor's protocol ID
- GLO-001
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. 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 Teeth Whitening in Patients With Gingivitis and Periodontitis
- ClinicalTrials.gov ID
- NCT02906982
- Acronym / sponsor ID
- GLO-001
- Conditions
- Tooth Discoloration, Periodontal Diseases
- Keywords
- Periodontal diseases, Periodontitis, Gingivitis, Teeth Whitening, Dental Plaque Index, Periodontal Index, Teeth Whitening Agents, Tooth Discoloration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Glo Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- EEC Institute, Inc.
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Sep 2016 (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 evaluate the efficacy of a novel gum health formulation, when used in an intra-oral device or on a toothbrush, for teeth whitening and clinical improvements in periodontal diseases.
Detailed description
Over half of the American population suffers from some form of periodontal disease, while millions of Americans are electing for teeth whitening procedures every year. The study is designed to assess the efficacy of a novel gum health formulation on teeth whitening in the context of gingival inflammation. Further, the study aims to assess the efficacy of the novel gum health formulation as an adjunct to the current standard of care in the treatment of gingivitis and periodontitis, depending on the severity of disease. As the dental professional community is whitening teeth in an environment of gingival inflammation, a single product that whitens teeth and controls inflammation is a novel treatment approach and highly desirable among patients and consumers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gum health formulation in intra-oral device | Experimental | Other: Gum health formulation in intra-oral deviceThe interventional gum health formulation is applied to the participant's mouth by means of an intra-oral device for a single eight-minute application, daily. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night. |
| Gum health formulation on toothbrush | Experimental | Other: Gum health formulation on toothbrushThe interventional gum health formulation is applied to the participant's mouth by means of a toothbrush and toothpaste, plus the gum health formulation, for two-minute applications, twice daily, morning and night. |
| Control group (split-mouth design) | No intervention | –The control group did not receive the interventional gum health formulation. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night. In addition, participants instructed to floss only half of their mouth daily, and the non-flossed half serves as the untreated comparative control receiving no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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 65 years of age
- A minimum of 20 teeth, excluding crowns and third molar teeth
- A mean whole mouth Gingival Index score of >2.0 at baseline
Key exclusion criteria (18 listed)
- Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta blockers
- Diagnosis of diabetes mellitus
- Presence of orthodontic appliances
- Presence of large restorations
- Crown or veneer at the anterior of both upper and lower teeth (including premolar teeth)
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 |
|---|---|---|
| Gum health formulation in intra-oral deviceAlso: ECO Balance, GLO Science intra-oral accelerating deviceThe intervention is a gum health formulation for periodontal disease care and teeth whitening to be used within an accelerating intra-oral device. | Other | Gum health formulation in intra-oral device |
| Gum health formulation on toothbrushAlso: ECO BalanceThe intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste. | Other | Gum health formulation on toothbrush |
Primary outcome
Change from Baseline Tooth Shade Value over 45 Days
Time frame: Baseline, Day 14, Day 28, Day 45
Tooth Shade Value was measured using a Vita Shade Guide and the measurement was transformed to a standardized value.
4 secondary outcomes
Plaque Index
Time frame: Baseline, Day 14, Day 28, Day 45
Gingival Index
Time frame: Baseline, Day 14, Day 28, Day 45
Bleeding Index
Time frame: Baseline, Day 14, Day 28, Day 45
Mean Probing Depth
Time frame: Baseline, Day 14, Day 28, Day 45
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 20 Sep 2016.
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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.
Edgard El Chaar, DDS, MS principal investigator
EEC Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum health formulation in intra-oral device and Gum health formulation on toothbrush in people with Tooth Discoloration and Periodontal Diseases, 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 11 inclusion and 18 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 20 Sep 2016. 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?
Change from Baseline Tooth Shade Value over 45 Days (time frame: Baseline, Day 14, Day 28, Day 45). 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 20 Sep 2016.