Complete DenturePhase 3NCT04942262
Oral Health-related Quality of Life and Masticatory Function After Using Denture Adhesive and Denture Liner
A Phase 3 study testing denture adhesive (Polident®, GlaxoSmithKline, Ireland) in people with Complete Denture and Complete Edentulism, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
80 complete denture (CD) wearers participated in the quasi-experimental study. Two outcomes were: 1) oral health-related quality of life (OHRQoL) assessed using the Oral Impacts on Daily Performances index, and 2) masticatory performance, determined by a peanut particle size after 20-stroke mastication. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Denture, Complete Edentulism
- What is being tested?
- denture adhesive (Polident®, GlaxoSmithKline, Ireland)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 31 Jan 2019to 30 Apr 2020
- Phase
- Phase 3
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Wear removable maxillary and mandibular complete dentures for at least 6 months.
Who cannot join
- Wear a metal-based denture
- Have a history of DA use
- Unable to respond to the interview
- Unwilling to follow the study protocol.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Dentistry, Chulalongkorn University
Pathum Wan, Bangkok, 10330
About this study
Official title: Identifying Diagnostic Criteria of Denture Adhesive Use in Complete Denture Wearers: A Quasi-experimental Study
80 complete denture (CD) wearers participated in the quasi-experimental study. Two outcomes were: 1) oral health-related quality of life (OHRQoL) assessed using the Oral Impacts on Daily Performances index, and 2) masticatory performance, determined by a peanut particle size after 20-stroke mastication. Denture retention and stability were evaluated using the Chulalongkorn University (CU)-modified Kapur method to classify the CD into acceptable or unacceptable quality. Data were collected at 3-time points: 1) at baseline (T0), 2) after a 1-month trial of denture adhesive (DA) use (T1), at which time the participants decided whether to continue using DA, and 3) 1-month after continued or discontinued using DA (T2).
Read the detailed description
Participants The eligible participants were CD wearers randomly recruited from patients who visited the Prosthodontic clinic at the Faculty of Dentistry, Chulalongkorn University from 2015 to 2019. The inclusion criteria were patients who had worn removable maxillary and mandibular CDs for at least 6 months. The patients who wore a metal-based denture, had a history of DA use, had difficulty in responding to the interview, or were unwilling to follow the study protocol were excluded from the study.
Outcomes The primary outcome was OHRQoL determined using the Thai-version of Oral Impacts on Daily Performances index. The participants were interviewed whether they had difficulties in performing the following 8 daily activities: eat, speak, clean denture and mouth, sleep, smile, emotional stability, social contact, and carry out work or housework. The frequency and severity of each impact were rated using a five-point Likert scale, and their multiplication gave a condition-specific impact score. The overall oral impact score was the sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence (score = 0) or presence of an oral impact (score > 0). The changes in oral impact score from T0 to T1 were categorized into 3 types: decreased (T0 score > T1 score), increased (T0 score < T1 score), and remained absent (T0 score = T1 score = 0).
The secondary outcome was masticatory performance assessed using the multiple sieve method of peanut mastication. The participants masticated 3 grams of roasted peanuts for 20 strokes in triplicate with a 15-minute resting interval between each test. The comminuted peanut particles were dried and sieved through 12 standard test sieves (Test sieve; Retcsh Technology GmbH) on a vibrating sieve shaker. A simple linear regression was plotted between the cumulative weight and diameter of each sieve test. The median peanut particle size (mm) was the sieve diameter through which 50% of the comminuted peanut particles passed. A smaller peanut particle size reflected a higher masticatory performance.
Intervention An external prosthodontist provided a cream-type DA (Polident®, GlaxoSmithKline, Ireland), and instructed the participants to use the DA cream once a day in the morning and use it throughout the day. They applied the DA onto maxillary and mandibular dentures on the tissue surface using a spot method. The participants had to remove the DA and clean the denture every day after the last meal by soaking and brushing the CD with liquid soap and a soft toothbrush under running tap water. Two gauze pads were used to remove DA from the denture and oral mucosa.
The OHRQoL, masticatory performance, and CD-quality were evaluated at 3-time points:
- T0, at baseline before using the DA. The baseline information regarding the outcomes was evaluated. Then, the participants underwent a daily 1-month trial of DA use,
- T1 (T0 + 1 month), after the 1-month trial period of DA use. The outcomes were evaluated with all participants using DA. The external prosthodontist asked the participants to choose whether they wanted to continue or discontinue using DA, and
- T2 (T0 + 2 months), at 1-month after continuing or discontinuing DA use. At this time, some participants used DA during the outcome evaluations, while some did not, depending on the patient's decision on DA use.
A single-blind clinical trial protocol was created. One of the investigators (B.T.) performed the outcome assessment who did not notice whether the participants continue using DA.
- Conditions
- Complete Denture, Complete Edentulism
- Being tested
- denture adhesive (Polident®, GlaxoSmithKline, Ireland)
- Keywords
- denture adhesive, oral impact, masticatory function, denture retention, denture stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denture adhesive (Polident®, GlaxoSmithKline, Ireland)Drug
Also called Polident
cream-type denture adhesive available as an over-the-counter product in Thailand
| Study group | Role | What they receive |
|---|---|---|
| denture adhesive use | Experimental | Participants were instructed to use a cream-type denture adhesive (Polident®, GlaxoSmithKline, Ireland) once a day in the morning and use it throughout the day. They applied denture adhesive onto the tissue surface of their maxillary and mandibular dentures using a spot method. The participants had to remove the DA and clean the denture every day after the last meal by soaking and brushing the CD with liquid soap and a soft toothbrush under running tap water. Two gauze pads were used to remove DA from the denture and oral mucosa. After the 1-month trial period of DA use. The outcomes were evaluated with all participants using DA, and they had to choose whether they wanted to continue or discontinue using DA for another 1 month. At 1-month after continuing or discontinuing DA use. At this time, some participants used DA during the outcome evaluations, while some did not, depending on the patient's decision on DA use. Receives: Drug: denture adhesive (Polident®, GlaxoSmithKline, Ireland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health-related quality of life (OHRQoL)
The OHRQoL was assessed using the oral impacts on daily performances (OIDP) index. The participants were interviewed about whether they had difficulties in performing the following 8 daily activities within physical, psychological and social performances: eating, speaking and pronouncing, cleaning denture and mouth, sleeping, smiling, emotional stability, social contact, and carrying out work or housework. The frequency and severity of each impact were rated using a five-point Likert scale, and their multiplication gave a condition-specific (CS) impact score. The overall oral impact score was the sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence (score = 0) or presence of an oral impact (score > 0).
Measured: 2 months
Secondary outcomes (1)
Masticatory performance using the multiple sieve method of peanut particle.
The participants masticated 3 grams of roasted peanuts for 20 strokes in triplicate with a 15-minute resting interval between each test. The comminuted peanut particles were dried and sieved through 12 standard test sieves (Test sieve; retch Technology GmbH) on a vibrating sieve shaker. A simple linear regression was plotted between the cumulative weight and diameter of each sieve test. The median peanut particle size (mm) was the sieve diameter through which 50% of the comminuted peanut particles passed. A smaller peanut particle size reflected a higher masticatory performance.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start31 Jan 2019
- Primary completion17 Jan 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complete DentureStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after intervention, and then allow the participants to decide whether to continue receiving the intervention
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nareudee Limpuangthip, DDS, PhD, Chulalongkorn University
- Investigators
- Nareudee Limpuangthip, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942262
- Sponsor's protocol ID
- HREC-DCU 2019-068
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Limpuangthip N, Somkotra T, Arksornnukit M. Modified retention and stability criteria for complete denture wearers: A risk assessment tool for impaired masticatory ability and oral health-related quality of life. J Prosthet Dent. 2018 Jul;120(1):43-49. doi: 10.1016/j.prosdent.2017.09.010. Epub 2017 Nov 29.
PubMed 29195820Nicolas E, Veyrune JL, Lassauzay C. A six-month assessment of oral health-related quality of life of complete denture wearers using denture adhesive: a pilot study. J Prosthodont. 2010 Aug;19(6):443-8. doi: 10.1111/j.1532-849X.2010.00601.x. Epub 2010 Apr 29.
PubMed 20456031Ohwada G, Minakuchi S, Sato Y, Kondo H, Nomura T, Tsuboi A, Hong G, Itoh Y, Kawai Y, Kimoto S, Gunji A, Suzuki A, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Subjective Evaluation of Denture Adhesives: A Multicenter Randomized Controlled Trial. JDR Clin Trans Res. 2020 Jan;5(1):50-61. doi: 10.1177/2380084419837607. Epub 2019 Apr 11.
PubMed 30975019
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Diagnostic Criteria of Denture Adhesive Use in Complete Denture Wearers: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04942262
- Acronym / sponsor ID
- HREC-DCU 2019-068
- Conditions
- Complete Denture, Complete Edentulism
- Keywords
- denture adhesive, oral impact, masticatory function, denture retention, denture stability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 28 Jun 2021 (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.
80 complete denture (CD) wearers participated in the quasi-experimental study. Two outcomes were: 1) oral health-related quality of life (OHRQoL) assessed using the Oral Impacts on Daily Performances index, and 2) masticatory performance, determined by a peanut particle size after 20-stroke mastication. Denture retention and stability were evaluated using the Chulalongkorn University (CU)-modified Kapur method to classify the CD into acceptable or unacceptable quality. Data were collected at 3-time points: 1) at baseline (T0), 2) after a 1-month trial of denture adhesive (DA) use (T1), at which time the participants decided whether to continue using DA, and 3) 1-month after continued or discontinued using DA (T2).
Detailed description
Participants The eligible participants were CD wearers randomly recruited from patients who visited the Prosthodontic clinic at the Faculty of Dentistry, Chulalongkorn University from 2015 to 2019. The inclusion criteria were patients who had worn removable maxillary and mandibular CDs for at least 6 months. The patients who wore a metal-based denture, had a history of DA use, had difficulty in responding to the interview, or were unwilling to follow the study protocol were excluded from the study.
Outcomes The primary outcome was OHRQoL determined using the Thai-version of Oral Impacts on Daily Performances index. The participants were interviewed whether they had difficulties in performing the following 8 daily activities: eat, speak, clean denture and mouth, sleep, smile, emotional stability, social contact, and carry out work or housework. The frequency and severity of each impact were rated using a five-point Likert scale, and their multiplication gave a condition-specific impact score. The overall oral impact score was the sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence (score = 0) or presence of an oral impact (score > 0). The changes in oral impact score from T0 to T1 were categorized into 3 types: decreased (T0 score > T1 score), increased (T0 score < T1 score), and remained absent (T0 score = T1 score = 0).
The secondary outcome was masticatory performance assessed using the multiple sieve method of peanut mastication. The participants masticated 3 grams of roasted peanuts for 20 strokes in triplicate with a 15-minute resting interval between each test. The comminuted peanut particles were dried and sieved through 12 standard test sieves (Test sieve; Retcsh Technology GmbH) on a vibrating sieve shaker. A simple linear regression was plotted between the cumulative weight and diameter of each sieve test. The median peanut particle size (mm) was the sieve diameter through which 50% of the comminuted peanut particles passed. A smaller peanut particle size reflected a higher masticatory performance.
Intervention An external prosthodontist provided a cream-type DA (Polident®, GlaxoSmithKline, Ireland), and instructed the participants to use the DA cream once a day in the morning and use it throughout the day. They applied the DA onto maxillary and mandibular dentures on the tissue surface using a spot method. The participants had to remove the DA and clean the denture every day after the last meal by soaking and brushing the CD with liquid soap and a soft toothbrush under running tap water. Two gauze pads were used to remove DA from the denture and oral mucosa.
The OHRQoL, masticatory performance, and CD-quality were evaluated at 3-time points:
- T0, at baseline before using the DA. The baseline information regarding the outcomes was evaluated. Then, the participants underwent a daily 1-month trial of DA use,
- T1 (T0 + 1 month), after the 1-month trial period of DA use. The outcomes were evaluated with all participants using DA. The external prosthodontist asked the participants to choose whether they wanted to continue or discontinue using DA, and
- T2 (T0 + 2 months), at 1-month after continuing or discontinuing DA use. At this time, some participants used DA during the outcome evaluations, while some did not, depending on the patient's decision on DA use.
A single-blind clinical trial protocol was created. One of the investigators (B.T.) performed the outcome assessment who did not notice whether the participants continue using DA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after intervention, and then allow the participants to decide whether to continue receiving the intervention
| Arm | Type | Receives |
|---|---|---|
| denture adhesive use | Experimental | Drug: denture adhesive (Polident®, GlaxoSmithKline, Ireland)Participants were instructed to use a cream-type denture adhesive (Polident®, GlaxoSmithKline, Ireland) once a day in the morning and use it throughout the day. They applied denture adhesive onto the tissue surface of their maxillary and mandibular dentures using a spot method. The participants had to remove the DA and clean the denture every day after the last meal by soaking and brushing the CD with liquid soap and a soft toothbrush under running tap water. Two gauze pads were used to remove DA from the denture and oral mucosa. After the 1-month trial period of DA use. The outcomes were evaluated with all participants using DA, and they had to choose whether they wanted to continue or discontinue using DA for another 1 month. At 1-month after continuing or discontinuing DA use. At this time, some participants used DA during the outcome evaluations, while some did not, depending on the patient's decision on DA use. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Wear removable maxillary and mandibular complete dentures for at least 6 months.
Key exclusion criteria (4 listed)
- Wear a metal-based denture
- Have a history of DA use
- Unable to respond to the interview
- Unwilling to follow the study protocol.
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 |
|---|---|---|
| denture adhesive (Polident®, GlaxoSmithKline, Ireland)Also: Polidentcream-type denture adhesive available as an over-the-counter product in Thailand | Drug | denture adhesive use |
Primary outcome
Oral health-related quality of life (OHRQoL)
Time frame: 2 months
The OHRQoL was assessed using the oral impacts on daily performances (OIDP) index. The participants were interviewed about whether they had difficulties in performing the following 8 daily activities within physical, psychological and social performances: eating, speaking and pronouncing, cleaning denture and mouth, sleeping, smiling, emotional stability, social contact, and carrying out work or housework. The frequency and severity of each impact were rated using a five-point Likert scale, and their multiplication gave a condition-specific (CS) impact score. The overall oral impact score was the sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence (score = 0) or presence of an oral impact (score > 0).
1 secondary outcome
Masticatory performance using the multiple sieve method of peanut particle.
Time frame: 2 months
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 28 Jun 2021.
- Background: PubMed 29195820Limpuangthip N, Somkotra T, Arksornnukit M. Modified retention and stability criteria for complete denture wearers: A risk assessment tool for impaired masticatory ability and oral health-related quality of life. J Prosthet Dent. 2018 Jul;120(1):43-49. doi: 10.1016/j.prosdent.2017.09.010. Epub 2017 Nov 29.
- Results publication: PubMed 20456031Nicolas E, Veyrune JL, Lassauzay C. A six-month assessment of oral health-related quality of life of complete denture wearers using denture adhesive: a pilot study. J Prosthodont. 2010 Aug;19(6):443-8. doi: 10.1111/j.1532-849X.2010.00601.x. Epub 2010 Apr 29.
- Results publication: PubMed 30975019Ohwada G, Minakuchi S, Sato Y, Kondo H, Nomura T, Tsuboi A, Hong G, Itoh Y, Kawai Y, Kimoto S, Gunji A, Suzuki A, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Subjective Evaluation of Denture Adhesives: A Multicenter Randomized Controlled Trial. JDR Clin Trans Res. 2020 Jan;5(1):50-61. doi: 10.1177/2380084419837607. Epub 2019 Apr 11.
- Individual participant dataSharing planned: No
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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.
Nareudee Limpuangthip principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing denture adhesive (Polident®, GlaxoSmithKline, Ireland) in people with Complete Denture and Complete Edentulism, run by Chulalongkorn University at 1 site in Thailand.
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 1 inclusion and 4 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 28 Jun 2021. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Oral health-related quality of life (OHRQoL) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942262, which also lists 3 linked publications.
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 28 Jun 2021.