- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07761715
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 augusti 2026 uppdaterad 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
Indiana
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Fort Wayne, Indiana, Förenta staterna, 46825
- Salus Research, Inc.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Whitening Tandkräm
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Tandkräm med fläckborttagningsförmåga
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Placebo-jämförare: Icke-blekande tandkräm
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Tandkräm med fläckborttagningsförmåga
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Tooth color
Tidsram: 4 weeks
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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.
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4 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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ORAL SOFT TISSUE INTEGRITY
Tidsram: 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.
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4 WEEKS
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 maj 2026
Primärt slutförande (Faktisk)
30 juni 2026
Avslutad studie (Faktisk)
30 juni 2026
Studieregistreringsdatum
Först inskickad
8 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
8 augusti 2026
Första postat (Faktisk)
12 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BOKA-WHT-2026-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .