DentaldentureNCT06397599
Denture Adhesive is a Patient Advantageous or Prosthetic Failure During Adaption Period: Randomized Control
A study testing denture adhesive in people with Dental, run by Cairo University at 1 site in Egypt.
Trial summary
Introduction: the complete denture wearers mainly complain of decrease of denture retention which affects on patient's quality of life Objective: to evaluate oral health-related quality of life (OHRQoL) of denture adhesive for completely edentulous denture wearers. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Dental
- What is being tested?
- denture adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2023to 20 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely edentulous
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: the complete denture wearers mainly complain of decrease of denture retention which affects on patient's quality of life Objective: to evaluate oral health-related quality of life (OHRQoL) of denture adhesive for completely edentulous denture wearers.
Material and methods : 32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.
Read the detailed description
32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.
- Conditions
- Dental
- Being tested
- denture adhesive
- Keywords
- Denture adhesives, quality of life and OHIP-EDENT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denture adhesiveOther
Also called use of adhesive for denture
use of adhesive for completely edentulous
| Study group | Role | What they receive |
|---|---|---|
| denture adhesive | Active comparator | use denture adhesive Receives: Other: denture adhesive |
| non adhesive | Active comparator | conventional denture without denture adhesive Receives: Other: denture adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients satisfaction
questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start12 Jan 2023
- Primary completion9 Nov 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DentalStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharaf Mohamed Yahia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397599
- Sponsor's protocol ID
- 6785/5
- Other IDs
- asharaf Email
- Acronym
- denture
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denture Adhesive is a Patient Advantageous or Prosthetic Failure During Adaption Period: Randomized Control
- ClinicalTrials.gov ID
- NCT06397599
- Acronym / sponsor ID
- denture / 6785/5
- Conditions
- Dental
- Keywords
- Denture adhesives, quality of life and OHIP-EDENT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 3 May 2024 (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.
Introduction: the complete denture wearers mainly complain of decrease of denture retention which affects on patient's quality of life Objective: to evaluate oral health-related quality of life (OHRQoL) of denture adhesive for completely edentulous denture wearers.
Material and methods : 32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.
Detailed description
32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| denture adhesive | Active comparator | Other: denture adhesiveuse denture adhesive |
| non adhesive | Active comparator | Other: denture adhesiveconventional denture without denture adhesive |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- completely edentulous
Key exclusion criteria (1 listed)
- no
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 adhesiveAlso: use of adhesive for dentureuse of adhesive for completely edentulous | Other | denture adhesive, non adhesive |
Primary outcome
patients satisfaction
Time frame: 6 months
questionnaires
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 3 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dental, run by Cairo University at 1 site in Egypt.
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 1 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 3 May 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 Egypt. 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?
patients satisfaction (time frame: 6 months). 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 3 May 2024.