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The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Sensitive Whitening Toothpaste, Containing 5% KNO3 (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains Over 4 Weeks of Unsupervised Use.

12. august 2026 oppdatert av: Boka LLC

The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains Over 4 Weeks of Unsupervised Use.

The Purpose of This Research Study is to Compare the Effectiveness of a Non-fluoride Whitening Toothpaste (Test) to That of a Non-whitening Fluoride Toothpaste (Negative Control) in Improving Tooth Whiteness (Removal of Extrinsic Stains Over 4 Weeks of Unsupervised Use.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46825
        • Salus Research, Inc.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Be ≥18 years old, ambulatory, and ni good general health as determined by the Study Examiner, based upon clinical observation and the Medical/Dental History.
  • Be able to understand and sign the Informed Consent, complete a Medical History form, understand and comply with all study directions, and be available for all exam periods.
  • Present with adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect) and continue to meet the inclusion criteria and not fall into the categories of exclusion during the period of the study.
  • Have a mean Macpherson Modified Lobene Stain Index (MLSI) score of ≥ 1.5 on the labial surfaces of at least 8 of 12 anterior teeth.
  • Have a minimum of 16 natural teeth.
  • Have had dental prophylaxis within the past 18 months, but not within the past 3 months, and agree to refrain from using al oral care products (other dentifrices and toothbrushes, dental floss, and mouthwashes), other than their assigned product, for the duration of the study.
  • Agree to refrain from using al whitening products and procedures for the duration of the study.
  • Drink stain-forming beverages daily.

Exclusion Criteria:

  • Have a history of serious medical conditions or transmittable diseases including but not limited to active hepatitis, heart irregularities, conditions requiring pre-medication for dental procedures, rheumatic heart disease, untreated diabetes mellitus, cirrhosis, leukemia, phenylketonuria, renal disease, sarcoidosis, tuberculosis, bleeding disorder, vascular disease, AIDS, history of drug allergies or idiosyncrasies, or any other medical condition that may preclude successful participation in the trial, at the discretion of the Study Examiner.
  • Have had prior significant adverse effects following the use of oral hygiene products.
  • Have the presence of orthodontic bands, retainers, fixed appliances, large restorations, or removable partial dentures, which may interfere with clinical assessments of the evaluable teeth.
  • Show evidence of neglected dental health in need of prompt professional attention (i.e., gross calculus deposits or rampant caries), significant oral soft tissue pathology, systemically related gingival enlargement, generalized recession, tissue damage due to ill-fitting appliances or restorations, or extreme crowding or overlapping of teeth. Periodontitis (ADA Class I, I, or IV), e.g., more than two teeth with periodontal pockets >4 mm as evidenced by purulent exudate, tooth mobility, and other signs indicating that the integrity of the data collected might be compromised.
  • Have medication therapy that is current and ongoing or within the past 4 weeks, which might interfere with the outcome of the study by affecting oral tissue condition, salivation, or stain formation (particularly chronic long-term medication therapy).
  • Are you nursing (breast-feeding) or pregnant.
  • Present at baseline with any reported sensory reactions, observed gum irritation, or any condition that would interfere with subsequent clinical assessments, or subjects with a history of allergy ot oral care products, severe oral cavity sensitivity, or excessive oral irritation.
  • Have participated in tooth bleaching or whitening dentifrice trials within the last three months.
  • Have had professional or at-home bleaching during the last 6 months.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Whitening Tannkrem
Tannkrem med flekkfjernende evner
Placebo komparator: Ikke-blekende tannkrem
Tannkrem med flekkfjernende evner

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tooth color
Tidsramme: 4 weeks
The Modified Lobene Stain Index (MLSI) Area x Intensity score for the overall tooth surfaces will be used for measurement of tooth color. The Primary Endpoint is the MLSI (extrinsic stain mean scores) at the 4-week time point compared to baseline.
4 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ORAL SOFT TISSUE INTEGRITY
Tidsramme: 4 WEEKS
To determine the oral soft tissue (OST) tolerance of the dentifrices. To compare the change from baseline in stain levels as represented by the MLSI scores for overall, gingival, interproximal and body areas of the facial and lingual surfaces for each dentifrice after 4 weeks of product use.
4 WEEKS

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. mai 2026

Primær fullføring (Faktiske)

30. juni 2026

Studiet fullført (Faktiske)

30. juni 2026

Datoer for studieregistrering

Først innsendt

8. august 2026

Først innsendt som oppfylte QC-kriteriene

8. august 2026

Først lagt ut (Faktiske)

12. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere