Complete EdentulismNCT05496283
Effect of Denture Adhesives on Complete Denture Patients
A study testing denture adhesive in people with Complete Edentulism, run by University of Jordan at 1 site in Jordan.
Trial summary
The effect of using denture adhesives on patient satisfaction with complete dentures; A randomized clinical trial. The study evaluates the effect of using 3 types of denture adhesives on patient satisfaction and quality of life of complete denture patients Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- denture adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 10 Feb 2022to 28 Feb 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients seeking new conventional complete dentures for first time
- Patients aged 40-85 years
- Must be completely edentulous for at least 6 months
- Must have well-developed to moderately resorbed maxillary and mandibular ridges
- Must have no denture fissuratum or any traumas from previous dentures
- Must be able to complete and sign the consent form
Who cannot join
- Patients with relevant medical issues, disorders of masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect response to treatment
- Patients with oral pathology, xerostomia, or tied tongue condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Denture Adhesives on Patient Satisfaction With Complete Dentures; A Randomized Clinical Trial
The effect of using denture adhesives on patient satisfaction with complete dentures; A randomized clinical trial.
The study evaluates the effect of using 3 types of denture adhesives on patient satisfaction and quality of life of complete denture patients
Read the detailed description
Aims: The aims of this study is to compare patient satisfaction and oral health quality of life without using denture adhesive and using 3 types of denture adhesives.
Materials and Methods: 60 completely edentulous patients attending the University of Jordan hospital seeking new sets of complete dentures will be randomly divided into 3 groups (n=20). At delivery of complete dentures, all patients will be given the dentures with no denture adhesive and will be given review appointments after one month of using the dentures. At review appointment, patients will be asked to rate their overall satisfaction and their satisfaction regarding comfort, retention, stability, and efficiency of mastication and speech on a 100-mm visual analog scale (VAS). Participants also will fill out the oral health impact profile for edentulous patients (OHIP-EDENT) questionnaire. Each group will then be given one type of denture adhesive to use; paste-based Corega denture adhesive (CO), Sea Bond maxillary and mandibular denture adhesive strips (SB) and oil-based Olivafix denture adhesive (OF). Patients will be given instructions on how to use each type of adhesive and will be provided with sufficient amount for 1 month. After 1 month, patients will be asked to fill out the same forms
- Conditions
- Complete Edentulism
- Being tested
- denture adhesive
- Keywords
- Complete dentures, Patient satisfaction, denture adhesives
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denture adhesiveOther
After 1 month of using the complete denture with no denture adhesives, patients fill up satisfaction and quality of life forms and given 1 of 3 types of denture adhesive to use for month to compare satisfaction and quality of life forms
| Study group | Role | What they receive |
|---|---|---|
| Corega | Experimental | Complete denture patients given Corega denture adhesive. Receives: Other: denture adhesive |
| OlivaFix | Experimental | Complete denture patients given OlivaFix denture adhesive. Receives: Other: denture adhesive |
| Sea.Bond | Experimental | Complete denture patients given Sea.Bond denture adhesive. Receives: Other: denture adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction form
10 aspects regarding patient satisfaction with dentures on 100mm visual analogue scale, with 0 value being completely unsatisfied and 100 for completely satisfied
Measured: 1 month after denture delivery
oral health impact profile for edentulous patients (OHIP-EDENT)
20 aspects linking the dentures with patient quality of life, with a range of values from 1 to five for each aspect, with 1 being the best and 5 being the worst.
Measured: I month after denture delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start10 Feb 2022
- Primary completion31 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complete EdentulismStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nadia Ereifej, University of Jordan
- Investigators
- Nadia Ereifej, PhD, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496283
- Sponsor's protocol ID
- NSEreifej
- Status last verified
- May 2023
- First submitted
- 7 Aug 2022
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ereifej NS, Oweis YG, Abu-Awwad M. The effect of using denture adhesives on patient satisfaction with complete dentures; a randomized clinical trial. BMC Oral Health. 2023 Dec 19;23(1):1027. doi: 10.1186/s12903-023-03757-7.
PubMed 38114958
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Denture Adhesives on Patient Satisfaction With Complete Dentures; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05496283
- Acronym / sponsor ID
- NSEreifej
- Conditions
- Complete Edentulism
- Keywords
- Complete dentures, Patient satisfaction, denture adhesives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 11 Aug 2022 (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.
The effect of using denture adhesives on patient satisfaction with complete dentures; A randomized clinical trial.
The study evaluates the effect of using 3 types of denture adhesives on patient satisfaction and quality of life of complete denture patients
Detailed description
Aims: The aims of this study is to compare patient satisfaction and oral health quality of life without using denture adhesive and using 3 types of denture adhesives.
Materials and Methods: 60 completely edentulous patients attending the University of Jordan hospital seeking new sets of complete dentures will be randomly divided into 3 groups (n=20). At delivery of complete dentures, all patients will be given the dentures with no denture adhesive and will be given review appointments after one month of using the dentures. At review appointment, patients will be asked to rate their overall satisfaction and their satisfaction regarding comfort, retention, stability, and efficiency of mastication and speech on a 100-mm visual analog scale (VAS). Participants also will fill out the oral health impact profile for edentulous patients (OHIP-EDENT) questionnaire. Each group will then be given one type of denture adhesive to use; paste-based Corega denture adhesive (CO), Sea Bond maxillary and mandibular denture adhesive strips (SB) and oil-based Olivafix denture adhesive (OF). Patients will be given instructions on how to use each type of adhesive and will be provided with sufficient amount for 1 month. After 1 month, patients will be asked to fill out the same forms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corega | Experimental | Other: denture adhesiveComplete denture patients given Corega denture adhesive. |
| OlivaFix | Experimental | Other: denture adhesiveComplete denture patients given OlivaFix denture adhesive. |
| Sea.Bond | Experimental | Other: denture adhesiveComplete denture patients given Sea.Bond denture adhesive. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients seeking new conventional complete dentures for first time
- Patients aged 40-85 years
- Must be completely edentulous for at least 6 months
- Must have well-developed to moderately resorbed maxillary and mandibular ridges
- Must have no denture fissuratum or any traumas from previous dentures
Key exclusion criteria (2 listed)
- Patients with relevant medical issues, disorders of masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect response to treatment
- Patients with oral pathology, xerostomia, or tied tongue condition.
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 adhesiveAfter 1 month of using the complete denture with no denture adhesives, patients fill up satisfaction and quality of life forms and given 1 of 3 types of denture adhesive to use for month to compare satisfaction and quality of life forms | Other | Corega, OlivaFix, Sea.Bond |
Primary outcome
Patient satisfaction form
Time frame: 1 month after denture delivery
10 aspects regarding patient satisfaction with dentures on 100mm visual analogue scale, with 0 value being completely unsatisfied and 100 for completely satisfied
oral health impact profile for edentulous patients (OHIP-EDENT)
Time frame: I month after denture delivery
20 aspects linking the dentures with patient quality of life, with a range of values from 1 to five for each aspect, with 1 being the best and 5 being the worst.
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 16 May 2023.
- Derived from this study: PubMed 38114958Ereifej NS, Oweis YG, Abu-Awwad M. The effect of using denture adhesives on patient satisfaction with complete dentures; a randomized clinical trial. BMC Oral Health. 2023 Dec 19;23(1):1027. doi: 10.1186/s12903-023-03757-7.
- 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.
Nadia Ereifej, PhD principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing denture adhesive in people with Complete Edentulism, run by University of Jordan at 1 site in Jordan.
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 6 inclusion and 2 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 16 May 2023. 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 Jordan. 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?
Patient satisfaction form (time frame: 1 month after denture delivery). The study lists 2 primary outcomes in all. 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 NCT05496283, which also lists 1 linked publication.
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 16 May 2023.