Partial-edentulismNCT06106243
Evaluation of Digital 3D Printed Temporary Removable Partial Denture.
A study testing The conventional heat pressing temporary flexible maxillary removable partial denture and 3D-printed and digitally designed temporary flexible maxillary removable partial denture in people with Partial-edentulism and Temporary Partial Denture, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible RDPs and conventionally-fabricated temporary flexible RDPs. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial-edentulism, Temporary Partial Denture, 3D Printing
- What is being tested?
- The conventional heat pressing temporary flexible maxillary removable partial denture and 3D-printed and digitally designed temporary flexible maxillary removable partial denture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2023to 30 Aug 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maxillary Class III, modification I partially edentulous patients that enables measuring the retention values intraorally without denture rotation.
- Fully dentulous or partially edentulous opposing mandibular arch.
- Patients that require temporary partial dentures for aesthetic reasons or as an interim denture during mouth rehabilitation treatment or after implant placement.
- Age range (30-55 years).
- Cooperative patients that are willing to attend all follow-up periods.
- Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
- Patients with healthy abutments and healthy periodontium and no more than grade I mobility.
Who cannot join
- Patients with Parkinson's disease
- Patients with xerostomia.
- Patients with a history of allergy to dentures made of resins.
- Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
- Patients with large irregular bony exostosis.
- Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry , Cairo university
Giza
Medhat Abdelaziz, MSC, 00201094023661, dr.medhatsameh@gmail.com
About this study
Official title: Oral Health-Related Quality of Life and Retention in Digitally Versus Conventionally Fabricated Flexible Removable Partial Dentures in Maxillary Class III Modification 1 Patients: A Cross-over Randomized Clinical Trial
This study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible RDPs and conventionally-fabricated temporary flexible RDPs.
- Conditions
- Partial-edentulism, Temporary Partial Denture, 3D Printing, Oral Health Related Quality of Life
- Being tested
- The conventional heat pressing temporary flexible maxillary removable partial denture, 3D-printed and digitally designed temporary flexible maxillary removable partial denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The conventional heat pressing temporary flexible maxillary removable partial dentureProcedure or surgery
An intraoral scan will be made for each patient's maxillary and mandibular jaws in addition to digital bite registration using (Medit i700; Medit corp.) the resultant data will be exported in the form of a Standard Tessellation Language (STL) file. The denture base and the teeth will be designed using computer-aided design software (Partial Cad, Dental CAD software). Each patient will receive two RDPs, fabricated with two different manufacturing techniques. Based on randomization, the patients will start by receiving either partial denture that is fabricated by conventional heat pressing technique of 3D printed castable resin (Cast V1resin) followed by partial denture that is fabricated by 3D printing of printable resin (Flexo denture base, resin) and teeth (permanent crown,resin) or the other way around. In 3D-printed RDP, the artificial teeth will be attached to the fabricated denture bases using printable denture base resin material
3D-printed and digitally designed temporary flexible maxillary removable partial dentureProcedure or surgery
3D-printed and digitally designed temporary flexible maxillary removable partial denture
| Study group | Role | What they receive |
|---|---|---|
| The conventional heat pressing temporary flexible maxillary removable partial denture | Active comparator | Not described Receives: Procedure: The conventional heat pressing temporary flexible maxillary removable partial denture |
| 3D-printed and digitally designed temporary flexible maxillary removable partial denture . | Experimental | Not described Receives: Procedure: 3D-printed and digitally designed temporary flexible maxillary removable partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health-related quality of life.
Oral health impact profile (OHIP 14) questionnaire will be used to asses the oral health-related quality of life
Measured: Baseline and 6 months
Retention of a removable partial denture
The retention will be measured using Digital Force Gauge attached to the denture polished surface while the patient is in supine position
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start2 Jun 2023
- Primary completion2 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-edentulismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medhat Sameh Shehata Abdelaziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106243
- Sponsor's protocol ID
- 7-7-23
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health-Related Quality of Life and Retention in Digitally Versus Conventionally Fabricated Flexible Removable Partial Dentures in Maxillary Class III Modification 1 Patients: A Cross-over Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06106243
- Acronym / sponsor ID
- 7-7-23
- Conditions
- Partial-edentulism, Temporary Partial Denture, 3D Printing, Oral Health Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 2 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 30 Oct 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.
This study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible RDPs and conventionally-fabricated temporary flexible RDPs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The conventional heat pressing temporary flexible maxillary removable partial denture | Active comparator | Procedure: The conventional heat pressing temporary flexible maxillary removable partial denture |
| 3D-printed and digitally designed temporary flexible maxillary removable partial denture . | Experimental | Procedure: 3D-printed and digitally designed temporary flexible maxillary removable partial denture |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Maxillary Class III, modification I partially edentulous patients that enables measuring the retention values intraorally without denture rotation.
- Fully dentulous or partially edentulous opposing mandibular arch.
- Patients that require temporary partial dentures for aesthetic reasons or as an interim denture during mouth rehabilitation treatment or after implant placement.
- Age range (30-55 years).
- Cooperative patients that are willing to attend all follow-up periods.
Key exclusion criteria (6 listed)
- Patients with Parkinson's disease
- Patients with xerostomia.
- Patients with a history of allergy to dentures made of resins.
- Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
- Patients with large irregular bony exostosis.
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 |
|---|---|---|
| The conventional heat pressing temporary flexible maxillary removable partial dentureAn intraoral scan will be made for each patient's maxillary and mandibular jaws in addition to digital bite registration using (Medit i700; Medit corp.) the resultant data will be exported in the form of a Standard Tessellation Language (STL) file. The denture base and the teeth will be designed using computer-aided design software (Partial Cad, Dental CAD software). Each patient will receive two RDPs, fabricated with two different manufacturing techniques. Based on randomization, the patients will start by receiving either partial denture that is fabricated by conventional heat pressing technique of 3D printed castable resin (Cast V1resin) followed by partial denture that is fabricated by 3D printing of printable resin (Flexo denture base, resin) and teeth (permanent crown,resin) or the other way around. In 3D-printed RDP, the artificial teeth will be attached to the fabricated denture bases using printable denture base resin material | Procedure or surgery | The conventional heat pressing temporary flexible maxillary removable partial denture |
| 3D-printed and digitally designed temporary flexible maxillary removable partial denture3D-printed and digitally designed temporary flexible maxillary removable partial denture | Procedure or surgery | 3D-printed and digitally designed temporary flexible maxillary removable partial denture . |
Primary outcome
Oral health-related quality of life.
Time frame: Baseline and 6 months
Oral health impact profile (OHIP 14) questionnaire will be used to asses the oral health-related quality of life
Retention of a removable partial denture
Time frame: Baseline and 6 months
The retention will be measured using Digital Force Gauge attached to the denture polished surface while the patient is in supine position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The conventional heat pressing temporary flexible maxillary removable partial denture and 3D-printed and digitally designed temporary flexible maxillary removable partial denture in people with Partial-edentulism and Temporary Partial Denture, 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 7 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medhat Abdelaziz, MSC (00201094023661, dr.medhatsameh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health-related quality of life. (time frame: Baseline and 6 months). 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 30 Oct 2023.