- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02937870
A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive
25 aprile 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
25
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
New Jersey
-
Bloomfield, New Jersey, Stati Uniti, 07003
- GSK Investigational Site
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 85 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Comparatore attivo: Reference Product
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
|
Adhesive Cream
|
|
Altro: Negative Control
|
No adhesive
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
7 marzo 2017
Completamento primario (Effettivo)
5 aprile 2017
Completamento dello studio (Effettivo)
5 aprile 2017
Date di iscrizione allo studio
Primo inviato
17 ottobre 2016
Primo inviato che soddisfa i criteri di controllo qualità
17 ottobre 2016
Primo Inserito (Stima)
19 ottobre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 maggio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 aprile 2018
Ultimo verificato
1 febbraio 2018
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 206233
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .