- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02937870
A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive
25. april 2018 oppdatert av: GlaxoSmithKline
A Proof of Principle Bite Force Study Using Two New Test Adhesives and a Currently Marketed Denture Adhesive.
The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite force study will be to compare bite force measurements over a 12 hour period across two (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This will be a 4-treatment, 4-period, randomized, crossover, proof of principle bite force study which will compare bite force measurements over a 12 hour period across two cream denture adhesives with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control.
A short questionnaire regarding the flavor and texture characteristics of each denture adhesive after a single use will also be administered to give an indication of participant satisfaction of these attributes.
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New Jersey
-
Bloomfield, New Jersey, Forente stater, 07003
- GSK Investigational Site
-
-
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
18 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged between 18 to 85 years.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination and absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
- Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture. Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. Maxillary dentures must be considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan Modification: retention score >=2, stability score >=2). Maxillary dentures and mandibular dentures, if present, must be considered to be well-made based on design and construction criteria specified in the protocol. The qualifying maxillary incisal bite force readings (without adhesive) must be less than or equal to 9 pounds (lb) at the Screening Visit and subsequent visit pre-treatment baseline bites. At least 2 of the 4 qualifying bite readings at the Screening Visit must be reproducible (+/- 2lb). At subsequent visits the bite force readings must be within +/-2lb for 1 of the 3 practice bites and the pre-treatment baseline bite.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
Exclusion Criteria:
- A woman who is known to be pregnant or who is intending to become pregnant (self reported) over the duration of the study.
- A woman who is breast-feeding.
- Implanted with a cardiac pacemaker.
- Daily doses of medication that might interfere with the ability to perform the study according to protocol (as determined by the Investigator).
- Taking or have taken a bisphosphonate drug for treatment of osteoporosis.
- A serious chronic disease requiring hospitalization.
- Any condition not previously mentioned that in the Investigator's opinion may impair the study evaluation.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] problems) that, in the opinion of the investigator, could affect the participant's participation in the study.
- Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements.
- Severe dry mouth that may affect denture retention in the opinion of the Investigator.
- OST examination findings such as stomatitis, open sores, lesions, redness or swelling that, in the opinion of the investigator, could affect the participant's participation in the study.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last year) of alcohol or other substance abuse.
- A participant who is unwilling to refrain from smoking, including e-cigarettes and the use of chewing tobacco or other tobacco products for the duration of screening and each treatment day (12-14 hours).
- An employee of the sponsor or the study site or members of their immediate family.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Test Product 1
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
Test adhesive 1 with a thin nozzle
|
Eksperimentell: Test Product 2
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
Test adhesive 2 with a thin nozzle
|
Aktiv komparator: Reference Product
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
Adhesive Cream
|
Annen: Negative Control
|
No adhesive
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive
Tidsramme: up to 12 hours
|
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force.
AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]).
AUC0-12 was calculated using the trapezoidal method.
This transformation returned the measurement to the same scale as the original observations.
Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
|
up to 12 hours
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive
Tidsramme: up to 12 hours
|
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force.
AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs).
AUC0-12 was calculated using the trapezoidal method.
This transformation returned the measurement to the same scale as the original observations.
Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
|
up to 12 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive
Tidsramme: up to 12 hours
|
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force.
AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs).
AUC0-12 was calculated using the trapezoidal method.
This transformation returned the measurement to the same scale as the original observations.
Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
|
up to 12 hours
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive
Tidsramme: up to 12 hours
|
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force.
AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs).
AUC0-12 was calculated using the trapezoidal method.
This transformation returned the measurement to the same scale as the original observations.
Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
|
up to 12 hours
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2
Tidsramme: up to 12 hours
|
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force.
AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs).
AUC0-12 was calculated using the trapezoidal method.
This transformation returned the measurement to the same scale as the original observations.
Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
|
up to 12 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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)
7. mars 2017
Primær fullføring (Faktiske)
5. april 2017
Studiet fullført (Faktiske)
5. april 2017
Datoer for studieregistrering
Først innsendt
17. oktober 2016
Først innsendt som oppfylte QC-kriteriene
17. oktober 2016
Først lagt ut (Anslag)
19. oktober 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. april 2018
Sist bekreftet
1. februar 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 206233
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
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. .
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