Complete EdentulismNCT06233552
Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading
A study testing conventional denture conversion and digital denture conversion in people with Complete Edentulism, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study presents a smart digital approach to design and construct a screw retained immediately loaded full arch implant supported bridge based on the pre-treatment complete denture. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- conventional denture conversion and digital denture conversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 31 Oct 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Nonsmokers
- Free from any systemic disease
- Non-bruxers
- With sufficient quality and quantity of bone
- Prepared to comply with the follow-up and maintenance program
Who cannot join
- - Patients with bad oral hygiene.
- Patients with limited mouth opening.
- Vulnerable groups.
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading: A Randomized Trial
This study presents a smart digital approach to design and construct a screw retained immediately loaded full arch implant supported bridge based on the pre-treatment complete denture.
Read the detailed description
After intra oral scanning of the ridge form, implant positions, the denture is used to scan the intermaxillary relation and tooth positions and the fixed interim is designed and milled from PMMA. This technique is applicable when a single arch is treated or for bimaxillary implant rehabilitation cases. In this study 30 patients were grouped into two groups; group I in which a converted denture was made conventionally and Group II in which a converted denture was made digitally. General satisfaction, chair side working time, and esthetic outcome of the prostheses were recorded and quantified with a verbal rating scale following insertion of implant-supported prosthesis.
- Conditions
- Complete Edentulism
- Being tested
- conventional denture conversion, digital denture conversion
- Keywords
- immediate loading, denture conversion, full arch implant rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional denture conversionProcedure or surgery
conventional workflow usually done to do immediate loading for full arch implant cases
digital denture conversionProcedure or surgery
An alternative workflow for construction of the fixed interim requires impressions, model production, and jaw relation records then digitizing all these data then designing and milling the restoration.
| Study group | Role | What they receive |
|---|---|---|
| conventional denture conversion | Active comparator | a conventional denture conversion will be done following the conventional fabrication technique. Receives: Procedure: conventional denture conversion |
| digital denture conversion | Experimental | An alternative workflow for construction of the fixed interim requires impressions, model production, and jaw relation records then digitizing all these data then designing and milling the restoration. Receives: Procedure: digital denture conversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient general satisfaction questionnaire
General satisfaction with a verbal rating scale range from 0 to 5, as 0 denotes the lowest value (worst) and 5 the highest value (best), following insertion of implant-supported prosthesis.
Measured: through study completion within 6 months
Secondary outcomes (2)
chair side working time questionnaire
the procedure working time with a verbal rating scale range from 0 to 5, as 0 denotes the lowest value (worst) and 5 the highest value (best), following insertion of implant-supported prosthesis.
Measured: through study completion within 6 months
esthetic satisfaction questionnaire
esthetic outcome of the prostheses with a verbal rating scale range from 0 to 5, as 0 denotes the lowest value (worst) and 5 the highest value (best), following insertion of implant-supported prosthesis.
Measured: through study completion within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Mar 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasmine Elsherbeeny, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233552
- Sponsor's protocol ID
- FDASU-Rec IR 102305
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06233552
- Acronym / sponsor ID
- FDASU-Rec IR 102305
- Conditions
- Complete Edentulism
- Keywords
- immediate loading, denture conversion, full arch implant rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 31 Jan 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.
This study presents a smart digital approach to design and construct a screw retained immediately loaded full arch implant supported bridge based on the pre-treatment complete denture.
Detailed description
After intra oral scanning of the ridge form, implant positions, the denture is used to scan the intermaxillary relation and tooth positions and the fixed interim is designed and milled from PMMA. This technique is applicable when a single arch is treated or for bimaxillary implant rehabilitation cases. In this study 30 patients were grouped into two groups; group I in which a converted denture was made conventionally and Group II in which a converted denture was made digitally. General satisfaction, chair side working time, and esthetic outcome of the prostheses were recorded and quantified with a verbal rating scale following insertion of implant-supported prosthesis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional denture conversion | Active comparator | Procedure: conventional denture conversiona conventional denture conversion will be done following the conventional fabrication technique. |
| digital denture conversion | Experimental | Procedure: digital denture conversionAn alternative workflow for construction of the fixed interim requires impressions, model production, and jaw relation records then digitizing all these data then designing and milling the restoration. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -Nonsmokers
- Free from any systemic disease
- Non-bruxers
- With sufficient quality and quantity of bone
- Prepared to comply with the follow-up and maintenance program
Key exclusion criteria (4 listed)
- - Patients with bad oral hygiene.
- Patients with limited mouth opening.
- Vulnerable groups.
- Uncooperative patients.
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 |
|---|---|---|
| conventional denture conversionconventional workflow usually done to do immediate loading for full arch implant cases | Procedure or surgery | conventional denture conversion |
| digital denture conversionAn alternative workflow for construction of the fixed interim requires impressions, model production, and jaw relation records then digitizing all these data then designing and milling the restoration. | Procedure or surgery | digital denture conversion |
Primary outcome
Patient general satisfaction questionnaire
Time frame: through study completion within 6 months
General satisfaction with a verbal rating scale range from 0 to 5, as 0 denotes the lowest value (worst) and 5 the highest value (best), following insertion of implant-supported prosthesis.
2 secondary outcomes
chair side working time questionnaire
Time frame: through study completion within 6 months
esthetic satisfaction questionnaire
Time frame: through study completion within 6 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 31 Jan 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 conventional denture conversion and digital denture conversion in people with Complete Edentulism, run by Ain Shams 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 5 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 31 Jan 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?
Patient general satisfaction questionnaire (time frame: through study completion within 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 31 Jan 2024.