- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02937870
A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive
25 april 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
25
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
New Jersey
-
Bloomfield, New Jersey, Verenigde Staten, 07003
- GSK Investigational Site
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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
|
Experimenteel: 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
|
Actieve vergelijker: Reference Product
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
Adhesive Cream
|
Ander: Negative Control
|
No adhesive
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
7 maart 2017
Primaire voltooiing (Werkelijk)
5 april 2017
Studie voltooiing (Werkelijk)
5 april 2017
Studieregistratiedata
Eerst ingediend
17 oktober 2016
Eerst ingediend dat voldeed aan de QC-criteria
17 oktober 2016
Eerst geplaatst (Schatting)
19 oktober 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
23 mei 2018
Laatste update ingediend die voldeed aan QC-criteria
25 april 2018
Laatst geverifieerd
1 februari 2018
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 206233
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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