- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02937870
A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive
25. april 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
25
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New Jersey
-
Bloomfield, New Jersey, Forenede Stater, 07003
- GSK Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
Eksperimentel: 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
|
Andet: Negative Control
|
No adhesive
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. marts 2017
Primær færdiggørelse (Faktiske)
5. april 2017
Studieafslutning (Faktiske)
5. april 2017
Datoer for studieregistrering
Først indsendt
17. oktober 2016
Først indsendt, der opfyldte QC-kriterier
17. oktober 2016
Først opslået (Skøn)
19. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. maj 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. april 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 206233
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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