Complete EdentulismNCT05069909
Simplified Versus Conventional Complete Dentures
A study testing Denture Fabrication technique in people with Complete Edentulism, run by University of Jordan at 1 site in Jordan.
Trial summary
The purpose of this randomized, double-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures fabricated using the conventional and simplified techniques. 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 Fabrication technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJordan
- Study dates
- 10 Sep 2019to 31 May 2021
- 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 or as replacement of their previous complete dentures
- Patients aged 40-85 y.
- Patients who had been completely edentulous for at least 6 months
- Patients who had well developed to moderately resorbed maxillary and mandibular ridges
- Patients who had no denture fissuratum or any traumas from previous dentures
- Patients who had no relevant medical issues, disorders of the masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect the response to treatment, oral pathology, xerostomia, or tied tongue condition.
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- Patients had medical and dental insurance to cover the fees for construction of dentures by a Prosthodontic specialist
- Patients who signed consent form
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial
The purpose of this randomized, double-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures fabricated using the conventional and simplified techniques.
Read the detailed description
40 completely edentulous patients, aged 40-85 years, with no relevant medical conditions, seeking complete dentures at a university hospital were included in this study. Those were randomly divided into two groups (n=20). Each group received two sets of dentures, the Group (S) were given the dentures constructed using the simplified technique first while the Group (C) received the dentures constructed using the conventional technique. After 1 month of the first set of dentures delivery, participants were asked to rate their general satisfaction on a 10-cm visual analogue scale in addition to their satisfaction regarding comfort, retention, stability, efficiency of mastication and speaking. Participants were also asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT). Thereafter, each group of patients were given the set of dentures constructed using the other technique, given instructions and recalled after 1 month to evaluate the alternate set of dentures. 2 Prosthodontists performed all the clinical procedures and 1 laboratory technician performed the laboratory procedures. The results of the study were analyzed using Wilcoxon-signed rank test at significance level of 0.05.
- Conditions
- Complete Edentulism
- Being tested
- Denture Fabrication technique
- Keywords
- Simplified dentures, impression techniques, complete edentulism, border moulding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denture Fabrication techniqueProcedure or surgery
Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared
| Study group | Role | What they receive |
|---|---|---|
| Conventional technique | Active comparator | The group of patients who received dentures fabricated with conventional technique first Receives: Procedure: Denture Fabrication technique |
| Simplified technique | Active comparator | The group of patients who received dentures fabricated with simplified technique first Receives: Procedure: Denture Fabrication technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction questionnaire
Visual analogue scale (0-10) for a 10 item questionnaire regarding patient satisfaction with the dentures
Measured: 1 month after denture delivery
OHIP-EDENT
20-item oral health impact profile for edentulous patients questionnaire
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 posted6 Oct 2021
- Study start10 Sep 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069909
- Sponsor's protocol ID
- NEreifej
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study Protocol, Data analyses and results of both questionnaires will be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT05069909
- Acronym / sponsor ID
- NEreifej
- Conditions
- Complete Edentulism
- Keywords
- Simplified dentures, impression techniques, complete edentulism, border moulding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 6 Oct 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.
The purpose of this randomized, double-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures fabricated using the conventional and simplified techniques.
Detailed description
40 completely edentulous patients, aged 40-85 years, with no relevant medical conditions, seeking complete dentures at a university hospital were included in this study. Those were randomly divided into two groups (n=20). Each group received two sets of dentures, the Group (S) were given the dentures constructed using the simplified technique first while the Group (C) received the dentures constructed using the conventional technique. After 1 month of the first set of dentures delivery, participants were asked to rate their general satisfaction on a 10-cm visual analogue scale in addition to their satisfaction regarding comfort, retention, stability, efficiency of mastication and speaking. Participants were also asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT). Thereafter, each group of patients were given the set of dentures constructed using the other technique, given instructions and recalled after 1 month to evaluate the alternate set of dentures. 2 Prosthodontists performed all the clinical procedures and 1 laboratory technician performed the laboratory procedures. The results of the study were analyzed using Wilcoxon-signed rank test at significance level of 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional technique | Active comparator | Procedure: Denture Fabrication techniqueThe group of patients who received dentures fabricated with conventional technique first |
| Simplified technique | Active comparator | Procedure: Denture Fabrication techniqueThe group of patients who received dentures fabricated with simplified technique first |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients seeking new conventional complete dentures for first time or as replacement of their previous complete dentures
- Patients aged 40-85 y.
- Patients who had been completely edentulous for at least 6 months
- Patients who had well developed to moderately resorbed maxillary and mandibular ridges
- Patients who had no denture fissuratum or any traumas from previous dentures
Key exclusion criteria (1 listed)
- -
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 Fabrication techniqueEach patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared | Procedure or surgery | Conventional technique, Simplified technique |
Primary outcome
Patient satisfaction questionnaire
Time frame: 1 month after denture delivery
Visual analogue scale (0-10) for a 10 item questionnaire regarding patient satisfaction with the dentures
OHIP-EDENT
Time frame: I month after denture delivery
20-item oral health impact profile for edentulous patients questionnaire
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 6 Oct 2021.
- Individual participant dataSharing planned: Undecided. Study Protocol, Data analyses and results of both questionnaires will be shared
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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 Fabrication technique 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 9 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 6 Oct 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 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 questionnaire (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?
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 6 Oct 2021.