Clinical trial NCT04473521: A Clinical Study to Assess Force Required to Dislodge Upper Denture With and Without Use of a Novel Denture Adhesive
Official title: A Clinical Study Assessing Maximum Maxillary Bite Force When Using a Novel Denture Adhesive Compared to Using No-adhesive
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Denture Retention
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2020-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the hold properties of an investigational denture adhesive using an established methodology called the maximum incisal bite force (BF), and Kapur-Olshan (KO) index for denture retention and stability. The effects of hot drinks and two questionnaires relating to participants' perception will also be assessed for the investigational denture adhesive.

Detailed description: This study will be a single-centre, controlled, randomized, single blind, 4-treatment, 4-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. This study consists of 5 visits (1 screening visit and 4 treatment periods including minimum washout period of 2 days between treatment visits). Participant's maxillary and mandibular dentures will be assessed for retention and stability using KO index and whether they are well made. Participants will be randomized to one of the 4 treatment groups i.e. No adhesive, Super Poligrip Free (SPF), Investigational Adhesive and Investigational Adhesive + Hot drink arm group and will undergo an oral soft tissue (OST) and Oral Hard Tissue (OHT) examination. Participants who will meet all the inclusion and no exclusion criteria will continue the study. Participants will complete the BF measurement, KO assessment, OST, OHT examination and participants 'perception questionnaire as per the schedule.

Eligibility criteria: Inclusion Criteria:

* Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
* A participant who is willing and able to comply with scheduled visits, and other study procedures.
* A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
* Participant with a completely edentulous maxillary arch restored with a conventional maxillary full denture with an acrylic base. The maxillary denture prosthesis must fulfil all of the following:

  1. At least moderately well-fitting (Kapur Index, Olshan Modification: retention score greater than or equal to (\>=)2, stability score \>=2) at the Screening (V1) visit,
  2. Are well made (according to the well-made assessment).
* Participant with BF measurements which satisfy the following criteria:

  1. The "qualifying" BF measurements (without adhesive) at V1 must be less than or equal to (=\<)9lbs.
  2. At least 2 of the 4 "qualifying" BF measurements (without adhesive) at V1 (Screening) must be reproducible (within +/-2lbs).
  3. The "Baseline" BF measurement (without adhesive) at V2-5 must be \<=9lbs.
  4. The "Baseline" BF measurement (without adhesive) at V2-5 and at least 1 of the 3 "practice" BF measurements must be within +/-2lbs of each other.
* A participant who is dentate in the mandibular arch or has a partial or full denture in the mandibular arch that is:

  1. sufficiently stable, in the opinion of the investigator, to enable the bite force determination to be performed.
  2. well made (according to the well-made assessment).

Exclusion Criteria:

* A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
* A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
* A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
* A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
* A participant who is breastfeeding.
* A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
* A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
* A participant who is currently taking or has taken a bisphosphonate drug (i.e., Fosamax, Actonel, Boniva).
* Use of any medication or condition (e.g. insulin dependent diabetes) that, in the opinion of the investigator, would interfere with the conduct of the study.
* A participant who has 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.
* A participant clinically identified as having an incisal bite relation or any other tooth abnormality which could affect the BF measurements or participant safety.
* A participant who has any condition or medication which, in the opinion of the investigator, is currently causing xerostomia or which would interfere with the conduct of the study.
* A participant with a recent history (within the last year) of alcohol or other substance abuse.
* A participant with OST examination findings (at V1) such as stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling which in the opinion of the investigator, would interfere with the conduct of the study.
* A participant who has previously been enrolled in this study.
* Any participant who can't comply with study requirements and/or who would not be able to reliably perform a valid bite at the examiner's discretion.

Primary outcomes:
measure: Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force (BF)
timeFrame: Up to 12 hours
Secondary outcomes:
measure: Area Over Baseline (AOB) at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal Bite Force
timeFrame: Baseline, at 0.5, 1, 3, 6 and 9 hours
measure: Kapur Olshan (KO) Index Scores for Denture Retention
timeFrame: Baseline, at 3 hours
measure: Kapur Olshan (KO) Index Scores for Denture Stability
timeFrame: Baseline, at 3 hours
measure: Composite Kapur Olshan (KO) Index Scores for Denture Retention and Stability
timeFrame: Baseline, at 3 hours
measure: Area Over Baseline (AOB) at 0.5, 1, 3, 6, 9 and 12 Hours to Compare Maximum Incisal Bite Force Following the Consumption of a Hot Drink
timeFrame: Baseline, at 0.5, 1, 3, 6, 9 and 12 hours
measure: Kapur Olshan (KO) Index Scores for Denture Retention Following the Consumption of a Hot Drink
timeFrame: Baseline, at 3 hours
measure: Kapur Olshan (KO) Index Scores for Denture Stability Following the Consumption of a Hot Drink
timeFrame: Baseline, at 3 hours
measure: Composite Kapur Olshan (KO) Index Scores for Denture Retention and Stability Following the Consumption of a Hot Drink
timeFrame: Baseline, at 3 hours
measure: Number of Participants who Feel Their Denture is More Stable and Secure After Using Adhesive
timeFrame: Baseline, 9 hr after the BF measurement
measure: Number of Participants who Feel Less Worried About Denture Slipping/Wobbling After Using Adhesive
timeFrame: Baseline, 9 hr after the BF measurement
measure: Number of Participants who Feel More Confident About Having Hot Food and Drinks After Using Adhesive
timeFrame: Baseline, 9 hr after the BF measurement
measure: Number of Participants who Experience Denture Adhesive OOZE After Using Adhesive
timeFrame: Baseline, at 0.5 hr prior to BF measurement
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: