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The purpose of this study is to investigate the hold properties of two experimental denture adhesives using established maximum incisal BF methodology.
This will be a single-centre, controlled, randomized, single-blind (with respect to the examiner performing the incisal BF measurements), 4-treatment, 4- period, cross-over study to evaluate the maximum maxillary BF in a population of full maxillary denture wearers. A currently marketed denture adhesive will be used as a positive control, whilst use of no adhesive will be employed as a negative control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Control | No Intervention | Denture adhesive will not be used. | |
| Positive Control | Active Comparator | A single application of 1 gram of Super Poligrip Free denture adhesive will be applied topically to oral tissues via the upper denture. |
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| Experimental Denture Adhesive 1 | Experimental | A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture. |
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| Experimental Denture Adhesive 2 | Experimental | A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super Poligrip Free | Device | A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force | Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve [AUC]0-12) divided by 12 minus baseline BF (pounds [lbs]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment). | Baseline and up to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF | Natural logged incisal BF measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-t was defined as AUC 0-t divided by "t" minus baseline BF (lbs), where "t" is equal to 0.5, 1, 3, 6 and 9 hours. AUC was calculated from 0 to "t" hours using the trapezoid method; denoted as AUC 0-t. This transformation was carried out to return the measurement to the same scale as the original observation. AOB for 0.5, 1, 3, 6 and 9 hours were analyzed using the trapezoid method. AOB 0-0.5, AOB 0-1, AOB 0-3, AOB 0-6, AOB 0-9 were analyzed for each of the three treatments in comparison to no adhesive treatment group. Higher values of AOB demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment). |
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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.
A 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:
A participant with BF measurements which satisfy all the following criteria:
A participant who is dentate in the mandibular arch or has a partial or full denture in the mandibular arch that is:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Health Research Institute Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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A total of 52 participants were screened, of which 45 were enrolled (7 screened participants failed to meet the required criteria for study participation). Forty-three participants were randomized to study treatment (2 enrolled participants were not randomized due to lost to follow-up prior to treatment assignment) and 41 participants completed the study.
All participants were recruited at a single center in United States of America (USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Denture Adhesive 1/Negative Control/Positive Control/Experimental Denture Adhesive 2 | Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1, followed by Negative Control (No Denture Adhesive), Positive Control (Super Poligrip Free Denture Adhesive) and Experimental Denture Adhesive 2 in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Visit 2, 1 Day) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2022 | Jun 9, 2023 |
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| Experimental Denture Adhesive 1 | Device | A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture. |
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| Experimental Denture Adhesive 2 | Device | A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture. |
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| Baseline, at 0.5, 1, 3, 6 and 9 hours |
| FG001 | Experimental Denture Adhesive 2/Positive Control/Negative Control/Experimental Denture Adhesive 1 | Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 2, followed by Positive Control (Super Poligrip Free Denture Adhesive), Negative Control (No Denture Adhesive) and Experimental Denture Adhesive 1 in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions. |
| FG002 | Negative Control/Experimental Denture Adhesive 2/Experimental Denture Adhesive 1/Positive Control | Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Negative Control (No Denture Adhesive), followed by Experimental Denture Adhesive 2, Experimental Denture Adhesive 1, Positive Control (Super Poligrip Free Denture Adhesive) in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions. |
| FG003 | Positive Control/Experimental Denture Adhesive 1/Experimental Denture Adhesive 2/Negative Control | Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Positive Control (Super Poligrip Free Denture Adhesive), followed by Experimental Denture Adhesive 1, Experimental Denture Adhesive 2, Negative Control (No Denture Adhesive) in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period 1 (at Least 1 to 28 Days) |
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| Period 2 (Visit 3, 1 Day) |
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| Washout Period 2 (at Least 1 to 28 Days) |
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| Period 3 (Visit 4, 1 Day) |
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| Washout Period 3 (at Least 1 to 28 Days) |
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| Period 4 (Visit 5, 1 Day) |
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Modified Intent-To-Treat (mITT) population: All randomized participants with at least one post baseline assessment of efficacy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | Participants received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1, Experimental Denture Adhesive 2, Positive control (Super Poligrip Free Denture Adhesive) to the upper denture or Negative control (No Denture Adhesive) as per randomization schedule. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force | Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve [AUC]0-12) divided by 12 minus baseline BF (pounds [lbs]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment). | mITT population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | lbs | Baseline and up to 12 hours |
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| Secondary | Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF | Natural logged incisal BF measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-t was defined as AUC 0-t divided by "t" minus baseline BF (lbs), where "t" is equal to 0.5, 1, 3, 6 and 9 hours. AUC was calculated from 0 to "t" hours using the trapezoid method; denoted as AUC 0-t. This transformation was carried out to return the measurement to the same scale as the original observation. AOB for 0.5, 1, 3, 6 and 9 hours were analyzed using the trapezoid method. AOB 0-0.5, AOB 0-1, AOB 0-3, AOB 0-6, AOB 0-9 were analyzed for each of the three treatments in comparison to no adhesive treatment group. Higher values of AOB demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment). | mITT population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | lbs | Baseline, at 0.5, 1, 3, 6 and 9 hours |
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All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Denture Adhesive 1 | Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions. | 0 | 41 | 0 | 41 | 6 | 41 |
| EG001 | Experimental Denture Adhesive 2 | Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 2 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions. | 0 | 42 | 0 | 42 | 3 | 42 |
| EG002 | Positive Control | Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Positive control (Super Poligrip Free denture adhesive) to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions. | 0 | 42 | 0 | 42 | 4 | 42 |
| EG003 | Negative Control | Participants of this arm did not receive any adhesive to apply on upper denture. | 0 | 42 | 0 | 42 | 3 | 42 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Sinus headache | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Musculoskeletal chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oral mucosal erythema | Gastrointestinal disorders | Systematic Assessment |
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| Oral discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Oral pruritus | Gastrointestinal disorders | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Gingival injury | Gastrointestinal disorders | Systematic Assessment |
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| Lip injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Mouth injury | Gastrointestinal disorders | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
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HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +447880182593 | ww.clinical-trial-register@haleon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 7, 2022 | Jun 9, 2023 | SAP_001.pdf |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| ANCOVA |
| 0.044 |
P-value included Bonferroni adjustment. |
| Mean Difference (Final Values) |
| 0.14 |
| 2-Sided |
| 95 |
| 0.00 |
| 0.28 |
ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participant included as a random effect. |
| Superiority |
| ANCOVA | 0.005 | unadjusted P-value was presented. | Mean Difference (Final Values) | 0.18 | 2-Sided | 95 | 0.06 | 0.30 | Superiority | ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect. |
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 2 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
| OG002 | Positive Control | Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Positive control (Super Poligrip Free denture adhesive) to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions. |
| OG003 | Negative Control | Participants of this arm did not receive any adhesive to apply on upper denture. |
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