DenturesRESONATENCT05689814
Retention, Stability and Performance Assessment of Denture Fixatives Versus no Fixative Control
A study testing Paraffin based Denture Fixative in people with Dentures, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
Trial summary
This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentures
- What is being tested?
- Paraffin based Denture Fixative
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with a completely edentulous maxillary [UPPER] arch restored with a conventional full acrylic-based complete denture and dentate, partial, or full edentulous mandibular [LOWER], which may be restored with a stable complete, partial or implant supported denture
- For complete denture wearers, maxillary [UPPER] dentures must be completely removable standard acrylic dentures, which are at least moderately well-fitting at the screening visit (modified (Olshan) Kapur Index: retention score ≥2, stability score ≥2)
- Male or female participants aged between 18 and 85 years at the time of signing the informed consent form
- Participants must have been using dentures daily for at least 6 months prior to the screening visit
- Dentures must have been made in the last 5 years;
- Dentures must be well-made based on design and construction in the opinion of the clinician
- No clinically significant and relevant abnormalities in medical history or upon oral examination
Who cannot join
- Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential)
- Daily doses of medication that might interfere with the ability to perform the study according to protocol or affect study assessments, for example, bisphosphonates (oral or intravenous) (as determined by the Investigator)
- 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), or recent (within last 6 months) oral surgery / intervention, or oral health concern that, in the opinion of the investigator, could affect the participant's participation in the study
- Participants with maxillofacial defects covered by prosthetics
- Self-reported and/or visual manifestations of severe dry mouth (xerostomia) that may affect denture retention in the opinion of the Investigator
- Participants with oral soft tissue examination findings such as stomatitis, open sores, ulcers, lesions, redness or swelling or associated lymphadenopathy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds
Leeds, West Yorkshire, LS2 9LU
About this study
Official title: A Single-centre, Randomised, 3-way Cross-over, Clinical Investigation Comparing Denture Fixative Versus no Fixative Performance in Full Denture Wearers and an Exploratory Substudy in Partial Denture Wearers
This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control
Read the detailed description
A single-centre, randomised, 3-way cross-over, clinical investigation comparing the performance of two denture fixative versus no denture fixative control in full denture wearers and an exploratory sub study in partial denture wearers. The study will assess the performance and tolerance of two denture fixative cream formulations (Paraffin based and Polydecene based) when applied to full dentures.
- Conditions
- Dentures
- Being tested
- Paraffin based Denture Fixative
- Keywords
- Denture Fixative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraffin based Denture FixativeDevice
Also called Denture Fixative
Denture fixative applied in strips to secure dentures in place
| Study group | Role | What they receive |
|---|---|---|
| Paraffin based Denture Fixative | Experimental | Participants will use the paraffin-based denture fixative to secure their denture for 4 days and an additional 21-35 days during the observational (safety) period in accordance with the randomization schedule. Receives: Device: Paraffin based Denture Fixative |
| Polydecene based Denture Fixative | Active comparator | Participants will use the polydecene based denture fixative to secure their denture for 4 days and an additional 21-35 days during the observational (safety) period in accordance with the randomization schedule. Receives: Device: Paraffin based Denture Fixative |
| No Denture Fixative Control | No intervention | Participants will continue to wear their dentures for 4 days and will not use any denture fixative as part of this study arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denture Retention Assessment at 1hour
To assess denture retention of full maxillary arch after 1 hour with and without denture fixative using the Modified (Olshan) Kapur Index. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative.
Measured: 1 hour after denture fixative application or no fixative control
Secondary outcomes (7)
Denture Retention Assessment at 5minutes and 30minutes
To assess denture retention in full maxillary arch (and mandibular arch in fully edentulous participants) using the Modified (Olshan) Kapur Index at 5 and 30 minutes. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative.
Measured: 5mins and 30 mins after denture fixative application or no fixative control
Denture Stability at 5minutes, 30minutes and 1hour
To assess denture stability in full mandibular arch (if present) using the Modified (Olshan) Kapur Index as separate scores at 5minutes, 30 minutes and 1 hour.
Measured: 5mins and 30 mins after denture fixative application or no fixative control
Denture Hold Assessment
To assess denture hold (retention and stability) at ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours using the Modified (Kulak) Kelsey questionnaire compared to no fixative control
Measured: ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours after denture fixative application or no fixative control
Gum Comfort Assessment
To assess gum comfort using the Gum Comfort questionnaire comparing denture fixative to no fixative control over periods of 4 days (change in overall mean score and individual responses)
Measured: At the end of each participant's day during the 4-day treatment period for each arm
Participant Satisfaction Assessment
To assess participant satisfaction of the denture fixatives using the Modified (Kulak) Kelsey questionnaire compared to no fixative control
Measured: At the end of each participant's day during the 4-day treatment period for each arm
Oral Health Assessment
To make a clinical assessment of the oral health impact profile of participants using the Oral Health Impact Profile-Edentulous (OHIP-EDENT) questionnaires after 4 days use of each of the dental fixatives administered and no fixative control.
Measured: To be completed once during the participant's clinic visit on days 2,3,4,5,6,7 and 8 comparing with and without fixative
Bite Force Assessment
To measure Bite force by means of a digital gnathometer to compare the denture fixatives to no fixative control
Measured: To be completed once during the participant's clinic visit on days 3, 5 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start30 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DenturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The denture fixative cream formulations will be tested in a 3-arm cross-over-design, where subjects will be randomised to a sequence including the two intervention (denture fixative) arms and a control (no fixative) arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Leeds
- Responsible party
- Sponsor
- Investigators
- Sue Pavitt, Professor, Principal investigator, Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689814
- Sponsor's protocol ID
- 0708501
- Acronym
- RESONATE
- Status last verified
- Jan 2024
- First submitted
- 9 Dec 2022
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared if required as per local regulations
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, 3-way Cross-over, Clinical Investigation Comparing Denture Fixative Versus no Fixative Performance in Full Denture Wearers and an Exploratory Substudy in Partial Denture Wearers
- ClinicalTrials.gov ID
- NCT05689814
- Acronym / sponsor ID
- RESONATE / 0708501
- Conditions
- Dentures
- Keywords
- Denture Fixative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Leeds
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation will evaluate the effectiveness, tolerability and safety of two denture fixative creams versus no fixative control
Detailed description
A single-centre, randomised, 3-way cross-over, clinical investigation comparing the performance of two denture fixative versus no denture fixative control in full denture wearers and an exploratory sub study in partial denture wearers. The study will assess the performance and tolerance of two denture fixative cream formulations (Paraffin based and Polydecene based) when applied to full dentures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The denture fixative cream formulations will be tested in a 3-arm cross-over-design, where subjects will be randomised to a sequence including the two intervention (denture fixative) arms and a control (no fixative) arm.
| Arm | Type | Receives |
|---|---|---|
| Paraffin based Denture Fixative | Experimental | Device: Paraffin based Denture FixativeParticipants will use the paraffin-based denture fixative to secure their denture for 4 days and an additional 21-35 days during the observational (safety) period in accordance with the randomization schedule. |
| Polydecene based Denture Fixative | Active comparator | Device: Paraffin based Denture FixativeParticipants will use the polydecene based denture fixative to secure their denture for 4 days and an additional 21-35 days during the observational (safety) period in accordance with the randomization schedule. |
| No Denture Fixative Control | No intervention | –Participants will continue to wear their dentures for 4 days and will not use any denture fixative as part of this study arm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with a completely edentulous maxillary [UPPER] arch restored with a conventional full acrylic-based complete denture and dentate, partial, or full edentulous mandibular [LOWER], which may be restored with a stable complete, partial or implant supported denture
- For complete denture wearers, maxillary [UPPER] dentures must be completely removable standard acrylic dentures, which are at least moderately well-fitting at the screening visit (modified (Olshan) Kapur Index: retention score ≥2, stability score ≥2)
- Male or female participants aged between 18 and 85 years at the time of signing the informed consent form
- Participants must have been using dentures daily for at least 6 months prior to the screening visit
- Dentures must have been made in the last 5 years;
Key exclusion criteria (7 listed)
- Female participants who are pregnant as confirmed by a positive pregnancy test (urine) or are lactating (applicable to female participants of childbearing potential)
- Daily doses of medication that might interfere with the ability to perform the study according to protocol or affect study assessments, for example, bisphosphonates (oral or intravenous) (as determined by the Investigator)
- 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), or recent (within last 6 months) oral surgery / intervention, or oral health concern that, in the opinion of the investigator, could affect the participant's participation in the study
- Participants with maxillofacial defects covered by prosthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paraffin based Denture FixativeAlso: Denture FixativeDenture fixative applied in strips to secure dentures in place | Device | Paraffin based Denture Fixative, Polydecene based Denture Fixative |
Primary outcome
Denture Retention Assessment at 1hour
Time frame: 1 hour after denture fixative application or no fixative control
To assess denture retention of full maxillary arch after 1 hour with and without denture fixative using the Modified (Olshan) Kapur Index. Retention will be measured on score of 0-5 to assess the nature of resistance offered by the denture/denture fixative to vertical force. The higher the score, the higher the retention ability of the denture and fixative.
7 secondary outcomes
Denture Retention Assessment at 5minutes and 30minutes
Time frame: 5mins and 30 mins after denture fixative application or no fixative control
Denture Stability at 5minutes, 30minutes and 1hour
Time frame: 5mins and 30 mins after denture fixative application or no fixative control
Denture Hold Assessment
Time frame: ≤2 hours, 2 to 4 hours, 4 to 6 hours and 6 to 12 hours after denture fixative application or no fixative control
Gum Comfort Assessment
Time frame: At the end of each participant's day during the 4-day treatment period for each arm
Participant Satisfaction Assessment
Time frame: At the end of each participant's day during the 4-day treatment period for each arm
Oral Health Assessment
Time frame: To be completed once during the participant's clinic visit on days 2,3,4,5,6,7 and 8 comparing with and without fixative
Bite Force Assessment
Time frame: To be completed once during the participant's clinic visit on days 3, 5 and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No. IPD will be shared if required as per local regulations
Related trials for Dentures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Pavitt, Professor principal investigator
Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin based Denture Fixative in people with Dentures, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Denture Retention Assessment at 1hour (time frame: 1 hour after denture fixative application or no fixative control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.