Dental PlaqueNCT02940821
Assessing the Effects of Three Oral Care Regimens
A study testing Toothbrushing, Fluoridated Dentifrice (.15% sodium monofluorophosphate) and Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) in people with Dental Plaque and Gingivitis, run by Pearl Network at 1 site in United States.
Trial summary
Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening: A randomized, person-centric, comparative effectiveness clinical research study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Gingivitis
- What is being tested?
- Toothbrushing, Fluoridated Dentifrice (.15% sodium monofluorophosphate) and Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2016to 27 Jul 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject males or females 18 to 70 years old (inclusive).
- Availability for the 6 months duration of the clinical research study
- Good general health
- Subject able and willing to follow study procedures and instructions
- Subject read, understood and signed an informed consent form
- Subject present with at least 20 natural teeth in the functional dentition (excluding third molars), including the following natural (uncrowned) teeth for shading: #6, #7, #8, #9, #10, #11
Who cannot join
- Potential subjects must NOT HAVE ANY of the following conditions:
- Presence of orthodontic bands
- Presence of partial removable dentures
- Tumor(s) of the soft or hard tissues of the oral cavity
- Restorations or crowns that would interfere with color measurements on the following teeth: #6, #7, #8 , #9, #10 \& #11 (upper six front teeth)
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
Show all 14Show fewer
- Five or more carious lesions requiring immediate restorative treatment
- Antibiotic use any time during the one month prior to entry into the study
- Participation in any other clinical study or test panel within the one month prior to entry into the study
- History of allergies to oral care/personal care consumer products or their ingredients.
- On any prescription medicines that might interfere with the study outcome
- An existing medical condition which prohibits eating or drinking for periods up to 4 hours
- History of alcohol or drug abuse
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Frederick A. Curro, DMD, PhD
Emerson, New Jersey, 07630
About this study
Official title: Assessing Three Oral Care Regimen on Plaque, Gingivitis, and Tooth Whitening
Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening: A randomized, person-centric, comparative effectiveness clinical research study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network.
Read the detailed description
Six month, five visit study of plaque, gingivitis, and tooth whitening with three randomized intervention groups using FDA marketed and approved products and devices. One hundred fifty (150) subjects from the patient base of 10 PEARL Network associated dental offices on the East Coast of the United States will be entered into the clinical research study. This is a post-marketing comparative effectiveness research study. Having a total of 5 visits over a six month period. Adverse events and side effects for the products used are being assessed.
- Conditions
- Dental Plaque, Gingivitis
- Being tested
- Toothbrushing, Fluoridated Dentifrice (.15% sodium monofluorophosphate), Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide), Whitening (4.5% hydrogen peroxide), Other Fluoridated Dentifrice (.454% stannous fluoride)
- Keywords
- Tooth Whitening
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothbrushingOther
Also called Toothbrush
Mechanical plaque removal
Fluoridated Dentifrice (.15% sodium monofluorophosphate)Other
Fluoridated dentifrice application
Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)Other
Also called Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) and toothbrushing
Application of Tooth Whitening Agent in Dentifrice
Whitening (4.5% hydrogen peroxide)Other
Application of Whitening Agent
Other Fluoridated Dentifrice (.454% stannous fluoride)Other
Also called Fluoridated dentifrice (.454% stannous fluoride)
Fluoridated dentifrice application
| Study group | Role | What they receive |
|---|---|---|
| Whitening and Dentifrice | Active comparator | Not described Receives: Other: Toothbrushing; Other: Whitening (4.5% hydrogen peroxide); Other: Other Fluoridated Dentifrice (.454% stannous fluoride) |
| Whitening Dentifrice | Active comparator | Not described Receives: Other: Toothbrushing; Other: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) |
| Dentifrice | Active comparator | Not described Receives: Other: Toothbrushing; Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth Whitening Shade Evaluation
Measured: 6 months
Secondary outcomes (3)
Patient Questionnaire
Measured: 6 months
Plaque Index
Measured: 6 months
Gingival Index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start30 May 2016
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Frederick A Curro, DMD, PhD, Study director, Pearl NetworkAshley C Grill, MPH, RDH, Principal investigator, Pearl Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940821
- Sponsor's protocol ID
- PRL1517
- Status last verified
- Nov 2017
- First submitted
- 6 Oct 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Three Oral Care Regimen on Plaque, Gingivitis, and Tooth Whitening
- ClinicalTrials.gov ID
- NCT02940821
- Acronym / sponsor ID
- PRL1517
- Conditions
- Dental Plaque, Gingivitis
- Keywords
- Tooth Whitening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Pearl NetworkResearch network
- Study start
- 30 May 2016 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 21 Oct 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.
Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening: A randomized, person-centric, comparative effectiveness clinical research study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network.
Detailed description
Six month, five visit study of plaque, gingivitis, and tooth whitening with three randomized intervention groups using FDA marketed and approved products and devices. One hundred fifty (150) subjects from the patient base of 10 PEARL Network associated dental offices on the East Coast of the United States will be entered into the clinical research study. This is a post-marketing comparative effectiveness research study. Having a total of 5 visits over a six month period. Adverse events and side effects for the products used are being assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whitening and Dentifrice | Active comparator | Other: Toothbrushing, Other: Whitening (4.5% hydrogen peroxide), Other: Other Fluoridated Dentifrice (.454% stannous fluoride) |
| Whitening Dentifrice | Active comparator | Other: Toothbrushing, Other: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) |
| Dentifrice | Active comparator | Other: Toothbrushing, Other: Fluoridated Dentifrice (.15% sodium monofluorophosphate) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject males or females 18 to 70 years old (inclusive).
- Availability for the 6 months duration of the clinical research study
- Good general health
- Subject able and willing to follow study procedures and instructions
- Subject read, understood and signed an informed consent form
Key exclusion criteria (14 listed)
- Presence of orthodontic bands
- Presence of partial removable dentures
- Tumor(s) of the soft or hard tissues of the oral cavity
- Restorations or crowns that would interfere with color measurements on the following teeth: #6, #7, #8 , #9, #10 \& #11 (upper six front teeth)
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
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 |
|---|---|---|
| ToothbrushingAlso: ToothbrushMechanical plaque removal | Other | Dentifrice, Whitening Dentifrice, Whitening and Dentifrice |
| Fluoridated Dentifrice (.15% sodium monofluorophosphate)Fluoridated dentifrice application | Other | Dentifrice |
| Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)Also: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) and toothbrushingApplication of Tooth Whitening Agent in Dentifrice | Other | Whitening Dentifrice |
| Whitening (4.5% hydrogen peroxide)Application of Whitening Agent | Other | Whitening and Dentifrice |
| Other Fluoridated Dentifrice (.454% stannous fluoride)Also: Fluoridated dentifrice (.454% stannous fluoride)Fluoridated dentifrice application | Other | Whitening and Dentifrice |
Primary outcome
Tooth Whitening Shade Evaluation
Time frame: 6 months
3 secondary outcomes
Patient Questionnaire
Time frame: 6 months
Plaque Index
Time frame: 6 months
Gingival Index
Time frame: 6 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 14 Nov 2017.
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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.
Frederick A Curro, DMD, PhD study director
Pearl Network
Ashley C Grill, MPH, RDH principal investigator
Pearl Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrushing, Fluoridated Dentifrice (.15% sodium monofluorophosphate) and Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) in people with Dental Plaque and Gingivitis, run by Pearl Network 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 6 inclusion and 14 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 14 Nov 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?
Tooth Whitening Shade Evaluation (time frame: 6 months). 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 14 Nov 2017.