NCT02940821

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

October 6, 2016

Last Update Submit

November 13, 2017

Conditions

Dental PlaqueGingivitis

Keywords

Tooth Whitening

Outcome Measures

Primary Outcomes (1)

  • Tooth Whitening Shade Evaluation

    6 months

Secondary Outcomes (3)

  • Patient Questionnaire

    6 months

  • Plaque Index

    6 months

  • Gingival Index

    6 months

Study Arms (3)

Whitening and Dentifrice

ACTIVE COMPARATOR
Other: ToothbrushingOther: Whitening (4.5% hydrogen peroxide)Other: Other Fluoridated Dentifrice (.454% stannous fluoride)

Whitening Dentifrice

ACTIVE COMPARATOR
Other: ToothbrushingOther: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)

Dentifrice

ACTIVE COMPARATOR
Other: ToothbrushingOther: Fluoridated Dentifrice (.15% sodium monofluorophosphate)

Interventions

ToothbrushingOTHER

Mechanical plaque removal

Also known as: Toothbrush
DentifriceWhitening DentifriceWhitening and Dentifrice
Fluoridated Dentifrice (.15% sodium monofluorophosphate)OTHER

Fluoridated dentifrice application

Dentifrice
Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)OTHER

Application of Tooth Whitening Agent in Dentifrice

Also known as: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) and toothbrushing
Whitening Dentifrice
Whitening (4.5% hydrogen peroxide)OTHER

Application of Whitening Agent

Whitening and Dentifrice
Other Fluoridated Dentifrice (.454% stannous fluoride)OTHER

Fluoridated dentifrice application

Also known as: Fluoridated dentifrice (.454% stannous fluoride)
Whitening and Dentifrice

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederick A. Curro, DMD, PhD

Emerson, New Jersey, 07630, United States

Location

MeSH Terms

Conditions

Dental PlaqueGingivitis

Interventions

ToothbrushingfluorophosphateTin FluoridesHydrogen Peroxide

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistryFluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsTin CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgriculturePeroxidesOxidesAnionsIonsElectrolytesReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic Chemicals

Study Officials

  • Frederick A Curro, DMD, PhD

    Pearl Network

    STUDY DIRECTOR

  • Ashley C Grill, MPH, RDH

    Pearl Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 21, 2016

Study Start

May 30, 2016

Primary Completion

July 27, 2017

Study Completion

July 27, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

US(1)