Complete EdentulismNCT06324292
Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers
A study testing complete denture, CG and complete denture, DG in people with Complete Edentulism, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- complete denture, CG and complete denture, DG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Apr 2024to 15 Sep 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- completely edentulous patients
- well formed edentulous ridge
- healthy, pink, non edematous mucosa of even thickness
Who cannot join
- heavy smokers
- patients with parafunctional habits, temporomandibular joint disorders or orofacial motor disorders
- patients with physicological or psychiatric condition
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry Ain Shams University
Cairo, 11361
Faculty of Dentistry, Ain Shams University
Cairo, 11361
ahmed MA mohamed, Bsc, Msc,MD, 01111191337 ext. 020, ahmedmostafa@dent.asu.edu.eg
About this study
Official title: Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers: Randomized Clinical Trial
The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction.
It is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture.
Read the detailed description
Although the aesthetic results of digitally constructed dentures might be satisfactory for the patients, there is still little clinical evidence for the effect of using digital smile design DSD in denture construction on the patient's satisfaction. So, the objective of the current study is to find the effect of digital smile design (DSD) on quality of life in complete denture wearers compared to the conventionally created one. The current study is planned to be a crossover randomized Controlled Trial (RCT). The principal investigator, participants and the statistician will be blinded. Simple randomization of the patients in the will take place using a computer generated list (Software informer, Informer Technologies Inc) and allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG). Parallel allocation in ratio 1:1 will take place. The names of the participants in both groups will be placed in closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For blinding and allocation concealment, a third party rather than the authors and participants will be the only one to know the key so that the authors and the participants won't know in which group the participant will be. Afterwards, the authors will be informed by the randomization to be tabulated.
- Conditions
- Complete Edentulism
- Being tested
- complete denture, CG, complete denture, DG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete denture, CGProcedure or surgery
fabrication of conventional complete denture followed by a digital denture
complete denture, DGProcedure or surgery
fabrication of digital complete denture followed by a conventional one
| Study group | Role | What they receive |
|---|---|---|
| conventional denture followed by a digital one | Active comparator | the participants will receive a conventional complete denture followed by a digital one having digital smile design Receives: Procedure: complete denture, CG |
| Digital denture followed by a conventional one | Active comparator | the participants will receive a digital complete denture having digital smile design followed by a conventional one Receives: Procedure: complete denture, DG |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life assessment
OHIP-19 questionnaires for the edentulous patient will be used. A likert scale from 0 to 5 will be employed which zero will denote the ' very bad" experience with the denture and 5 will denote the "excellent" experience
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
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.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The participants allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Abdelfatah, Ain Shams University
- Investigators
- Ahmed MA Mohamed, BDS MSc MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324292
- Sponsor's protocol ID
- FDASU-RecID112324
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan will be available matching the criteria of the journal. However, data will be available from the corresponding author upon request once the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06324292
- Acronym / sponsor ID
- FDASU-RecID112324
- Conditions
- Complete Edentulism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 21 Mar 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.
The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction.
It is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture.
Detailed description
Although the aesthetic results of digitally constructed dentures might be satisfactory for the patients, there is still little clinical evidence for the effect of using digital smile design DSD in denture construction on the patient's satisfaction. So, the objective of the current study is to find the effect of digital smile design (DSD) on quality of life in complete denture wearers compared to the conventionally created one. The current study is planned to be a crossover randomized Controlled Trial (RCT). The principal investigator, participants and the statistician will be blinded. Simple randomization of the patients in the will take place using a computer generated list (Software informer, Informer Technologies Inc) and allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG). Parallel allocation in ratio 1:1 will take place. The names of the participants in both groups will be placed in closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For blinding and allocation concealment, a third party rather than the authors and participants will be the only one to know the key so that the authors and the participants won't know in which group the participant will be. Afterwards, the authors will be informed by the randomization to be tabulated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG).
| Arm | Type | Receives |
|---|---|---|
| conventional denture followed by a digital one | Active comparator | Procedure: complete denture, CGthe participants will receive a conventional complete denture followed by a digital one having digital smile design |
| Digital denture followed by a conventional one | Active comparator | Procedure: complete denture, DGthe participants will receive a digital complete denture having digital smile design followed by a conventional one |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- completely edentulous patients
- well formed edentulous ridge
- healthy, pink, non edematous mucosa of even thickness
Key exclusion criteria (3 listed)
- heavy smokers
- patients with parafunctional habits, temporomandibular joint disorders or orofacial motor disorders
- patients with physicological or psychiatric 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 |
|---|---|---|
| complete denture, CGfabrication of conventional complete denture followed by a digital denture | Procedure or surgery | conventional denture followed by a digital one |
| complete denture, DGfabrication of digital complete denture followed by a conventional one | Procedure or surgery | Digital denture followed by a conventional one |
Primary outcome
quality of life assessment
Time frame: 3 months
OHIP-19 questionnaires for the edentulous patient will be used. A likert scale from 0 to 5 will be employed which zero will denote the ' very bad" experience with the denture and 5 will denote the "excellent" experience
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan will be available matching the criteria of the journal. However, data will be available from the corresponding author upon request once the paper is published.
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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.
Ahmed MA Mohamed, BDS MSc MD study chair
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complete denture, CG and complete denture, DG in people with Complete Edentulism, run by Ain Shams University at 2 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed MA Mohamed, BSc MSc,MD (01111191337 ext. 020, ahmedmostafa@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life assessment (time frame: 3 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 26 Mar 2024.