Denture, CompleteCRDNCT05845099
Conventional Versus Digital 3D Printed Complete Removable Dentures
A study testing Polymethyl Methacrylate-Based Complete Removable Dentures. and Photopolymerized Methacrylate- Based Complete Removable Dentures. in people with Denture, Complete, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study is a crossover, randomised, controlled clinical trial that will compare and evaluate patients' satisfaction and oral microbiota proliferation in two groups. Group I: Conventionally manufactured CRD Group II: 3D-printed (three-dimensionally printed) CAD/CAM (computer-aided design/computer-aided manufacturing)… Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Denture, Complete
- What is being tested?
- Polymethyl Methacrylate-Based Complete Removable Dentures. and Photopolymerized Methacrylate- Based Complete Removable Dentures.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 May 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 45 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who have been completely edentulous in both jaws (maxilla and mandible) for at least a year and require treatment with complete dentures.
- The age of patients ranges from 45 to 60 years old.
- Patients with a Class I maxillo-mandibular relationship.
- Patients with adequate inter-arch space.
- Patients with good neuromuscular control.
- Patients without any temporomandibular joint disorder.
Who cannot join
- Patients with any oral diseases that may affect complete denture construction.
- Patients with bad oral hygiene.
- Patients with oral parafunctional habits.
- Hysterical patients.
- Patients will undergo or have previously received chemotherapy or radiotherapy.
- Smokers or drug- addicted patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Microbial Adherence and Patients' Satisfaction in Conventional and Digital 3D Printed Complete Removable Dentures: A Cross Over Randomized Controlled Clinical Trial
The study is a crossover, randomised, controlled clinical trial that will compare and evaluate patients' satisfaction and oral microbiota proliferation in two groups. Group I: Conventionally manufactured CRD Group II: 3D-printed (three-dimensionally printed) CAD/CAM (computer-aided design/computer-aided manufacturing) manufactured CRD, The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.
Read the detailed description
The study will be performed at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. Eleven edentulous male patients will be selected and recruited for this clinical trial after the informed consent provided by Faculty of Dentistry Ain Shams University-Research Ethics Committee (FDASU-REC) is assigned. They will be rehabilitated with Conventional and 3D-printed CAD-CAM (computer-aided design/computer-aided manufacturing) CRD. Participants will be randomly assigned to receive either Conventional or 3D-Printed CAD/CAM-manufactured CRD for three months before crossing over to the other set. care provider , investigator and participants will be blinded to the group allocation. Outcomes will be evaluated, including patient satisfaction with dentures and oral microbial adherence. The outcomes will be measured at baseline and at 1 and 3 months. The obtained data will be recorded, tabulated, and statistically analyzed using the appropriate tests for comparison between each group.
- Conditions
- Denture, Complete
- Being tested
- Polymethyl Methacrylate-Based Complete Removable Dentures., Photopolymerized Methacrylate- Based Complete Removable Dentures.
- Keywords
- 3D printing, CAD/CAM, Complete dentures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymethyl Methacrylate-Based Complete Removable Dentures.Device
Also called Complete Removable Denture manufacturing
The patients will receive Complete Removable Dentures processed by Heat cured acrylic resin.
Photopolymerized Methacrylate- Based Complete Removable Dentures.Device
Also called 3D printed Removable Denture manufacturing
The patients will receive a 3D-printed removable denture digitally manufactured using a 3d printer device with light polymerized resin.
| Study group | Role | What they receive |
|---|---|---|
| Polymethyl Methacrylate-Based Complete Removable Dentures. | Active comparator | The patient will be provided by a CRD to restore his missing teeth which will be manufactured by heat curing processing technique Receives: Device: Polymethyl Methacrylate-Based Complete Removable Dentures. |
| Photopolymerized Methacrylate- Based Complete Removable Dentures. | Experimental | The patient will be provided by a CRD to restore his missing teeth which will be manufactured by 3D-printed (Digital Light Processing). Receives: Device: Photopolymerized Methacrylate- Based Complete Removable Dentures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of oral microorganism proliferation by talking swab from
Assessment of oral microorganism proliferation by talking swab from the internal surface of both types of CRD to asses the affinity of oral microorganisms.
Measured: 3 months
Secondary outcomes (1)
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures by using Patient's Denture Assessment questionnaire (PDA) and interpreting it by using Likert scale (higher score (scale no.5) indicates good outcome and lower score (scale no.1)indicates bad outcome)
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 posted6 May 2023
- Study start1 Dec 2022
- Primary completion1 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Denture, CompleteStudies 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
- Crossover
- Model description
- double blind single center crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia M Refai, Ain Shams University
- Investigators
- Omnia MS Refai, PHD, Study chair, lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry , Ain Shams UniversityHeba RF Elsarrif, PHD, Study director, Lecturer of Oral and Maxillofacial Prosthodontics College of oral and dental surgery Misr University for science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845099
- Sponsor's protocol ID
- FDASU-Re IR112224
- Acronym
- CRD
- Status last verified
- Sep 2024
- First submitted
- 30 Mar 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Srinivasan M, Kalberer N, Fankhauser N, Naharro M, Maniewicz S, Muller F. CAD-CAM complete removable dental prostheses: A double-blind, randomized, crossover clinical trial evaluating milled and 3D-printed dentures. J Dent. 2021 Dec;115:103842. doi: 10.1016/j.jdent.2021.103842. Epub 2021 Oct 9.
PubMed 34637889Baba NZ, AlRumaih HS, Goodacre BJ, Goodacre CJ. Current techniques in CAD/CAM denture fabrication. Gen Dent. 2016 Nov-Dec;64(6):23-28.
PubMed 27814252
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Microbial Adherence and Patients' Satisfaction in Conventional and Digital 3D Printed Complete Removable Dentures: A Cross Over Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05845099
- Acronym / sponsor ID
- CRD / FDASU-Re IR112224
- Conditions
- Denture, Complete
- Keywords
- 3D printing, CAD/CAM, Complete dentures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 6 May 2023 (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 study is a crossover, randomised, controlled clinical trial that will compare and evaluate patients' satisfaction and oral microbiota proliferation in two groups. Group I: Conventionally manufactured CRD Group II: 3D-printed (three-dimensionally printed) CAD/CAM (computer-aided design/computer-aided manufacturing) manufactured CRD, The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.
Detailed description
The study will be performed at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. Eleven edentulous male patients will be selected and recruited for this clinical trial after the informed consent provided by Faculty of Dentistry Ain Shams University-Research Ethics Committee (FDASU-REC) is assigned. They will be rehabilitated with Conventional and 3D-printed CAD-CAM (computer-aided design/computer-aided manufacturing) CRD. Participants will be randomly assigned to receive either Conventional or 3D-Printed CAD/CAM-manufactured CRD for three months before crossing over to the other set. care provider , investigator and participants will be blinded to the group allocation. Outcomes will be evaluated, including patient satisfaction with dentures and oral microbial adherence. The outcomes will be measured at baseline and at 1 and 3 months. The obtained data will be recorded, tabulated, and statistically analyzed using the appropriate tests for comparison between each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double blind single center crossover design
| Arm | Type | Receives |
|---|---|---|
| Polymethyl Methacrylate-Based Complete Removable Dentures. | Active comparator | Device: Polymethyl Methacrylate-Based Complete Removable Dentures.The patient will be provided by a CRD to restore his missing teeth which will be manufactured by heat curing processing technique |
| Photopolymerized Methacrylate- Based Complete Removable Dentures. | Experimental | Device: Photopolymerized Methacrylate- Based Complete Removable Dentures.The patient will be provided by a CRD to restore his missing teeth which will be manufactured by 3D-printed (Digital Light Processing). |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients who have been completely edentulous in both jaws (maxilla and mandible) for at least a year and require treatment with complete dentures.
- The age of patients ranges from 45 to 60 years old.
- Patients with a Class I maxillo-mandibular relationship.
- Patients with adequate inter-arch space.
- Patients with good neuromuscular control.
Key exclusion criteria (6 listed)
- Patients with any oral diseases that may affect complete denture construction.
- Patients with bad oral hygiene.
- Patients with oral parafunctional habits.
- Hysterical patients.
- Patients will undergo or have previously received chemotherapy or radiotherapy.
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 |
|---|---|---|
| Polymethyl Methacrylate-Based Complete Removable Dentures.Also: Complete Removable Denture manufacturingThe patients will receive Complete Removable Dentures processed by Heat cured acrylic resin. | Device | Polymethyl Methacrylate-Based Complete Removable Dentures. |
| Photopolymerized Methacrylate- Based Complete Removable Dentures.Also: 3D printed Removable Denture manufacturingThe patients will receive a 3D-printed removable denture digitally manufactured using a 3d printer device with light polymerized resin. | Device | Photopolymerized Methacrylate- Based Complete Removable Dentures. |
Primary outcome
Assessment of oral microorganism proliferation by talking swab from
Time frame: 3 months
Assessment of oral microorganism proliferation by talking swab from the internal surface of both types of CRD to asses the affinity of oral microorganisms.
1 secondary outcome
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures
Time frame: 3 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 5 Sep 2024.
- Background: PubMed 34637889Srinivasan M, Kalberer N, Fankhauser N, Naharro M, Maniewicz S, Muller F. CAD-CAM complete removable dental prostheses: A double-blind, randomized, crossover clinical trial evaluating milled and 3D-printed dentures. J Dent. 2021 Dec;115:103842. doi: 10.1016/j.jdent.2021.103842. Epub 2021 Oct 9.
- Background: PubMed 27814252Baba NZ, AlRumaih HS, Goodacre BJ, Goodacre CJ. Current techniques in CAD/CAM denture fabrication. Gen Dent. 2016 Nov-Dec;64(6):23-28.
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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.
Omnia MS Refai, PHD study chair
lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry , Ain Shams University
Heba RF Elsarrif, PHD study director
Lecturer of Oral and Maxillofacial Prosthodontics College of oral and dental surgery Misr University for science and technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymethyl Methacrylate-Based Complete Removable Dentures. and Photopolymerized Methacrylate- Based Complete Removable Dentures. in people with Denture, Complete, 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 6 inclusion and 6 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 5 Sep 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?
Assessment of oral microorganism proliferation by talking swab from (time frame: 3 months). 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 NCT05845099, which also lists 2 linked publications.
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 5 Sep 2024.