Denture, CompleteCAD/CAMNCT05895292
Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges
A study testing CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept. and CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. in people with Denture, Complete, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study is a within-subject randomized clinical trial that will compare and evaluate patients' satisfaction and digitally analyze denture space Confines. Group I: CAD/CAM. (computer-aided design/computer-aided manufacturing) Conventional complete dentures will be designed based on the bone support concept, Group II… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture, Complete
- What is being tested?
- CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept. and CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Apr 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
- The age of patients ranges from 50 to 80 years old.
- Patients with a resorbed mandibular ridge.
- Patients with a Class I maxillo-mandibular relationship
- Patients with adequate inter-arch space.
- Patients with good neuromuscular control.
- Patients without any tempo-mandibular 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.
- Drug-addicted patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Analysis of Denture Space Confines and Patient's Satisfaction for Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges.(Randomized Controlled Clinical Trial)
The study is a within-subject randomized clinical trial that will compare and evaluate patients' satisfaction and digitally analyze denture space Confines. Group I: CAD/CAM. (computer-aided design/computer-aided manufacturing) Conventional complete dentures will be designed based on the bone support concept, Group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. 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
This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: CAD/CAM conventional complete dentures will be designed based on the bone support concept, group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The study will be carried out on twelve completely edentulous patients exhibiting advanced residual ridge resorption, each patient will receive two sets of complete dentures in a random sequence, and each set of CDs will be worn for at least eight weeks after the last recall visit before assessments. Upon delivery of the second set of CDs, the first set will be withheld from the patient. For each denture set, patient satisfaction will be rated using a patient denture assessment PDA questionnaire that will be assessed via a Likert scale, the obtained scores will be used to compare the two denture types. Also by using special digital software, a comparison between group I and II virtual complete denture images will be conducted.
- Conditions
- Denture, Complete
- Being tested
- CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept., CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
- Keywords
- CAD/CAM, Denture, Complete, Patient Satisfaction, Dental Impression Technique
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.Device
The patients will receive complete removable dentures designed based on the bone-support concept and digitally manufactured using a milling machine.
CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.Device
The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machine
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept. | Experimental | The patient will be provided by a complete removable denture designed according to bone-support concept to restore his missing teeth which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks. Receives: Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept. |
| CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. | Active comparator | The patient will be provided with a complete removable denture designed according to the neutral-concept to restore his missing teeth, which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks. Receives: Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Analysis and Comparison of Denture Space Confines for CAD/CAM Dentures Based on the bone-support concept Versus based on the neutral-zone concept Restoring Mandibular Resorbed Ridges using "Medit compare" digital software.
comparing the position of the neutral zone to the software-designed anatomical denture confines using "Medit compare" digital software (Medit design, Medit Compare (V1.2), Seoul, South Korea). Average values of facio-lingual deviations between the two dentures in the premolar and molar regions, as well as the anterior region, will be calculated in millimeters, yielding five measurements for each patient's denture sets. Color maps for dimensional deviations of the overall as well as specified surfaces for both dentures revealing the qualitative 3D differences between them will be obtained. Measuring procedures will be similar, as recommended by the manufacturer and all will be performed by the same digital professional operator.
Measured: before manufacturing of complete removable denture
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: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 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.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895292
- Sponsor's protocol ID
- FDASU-RecIR012316
- Acronym
- CAD/CAM
- Status last verified
- Sep 2024
- First submitted
- 31 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bhorgonde D, Nandakumar K, Khurana PR, Kumari VS, Reddy MS, Siddique S. An evaluation of the position of the neutral zone in relation to the crest of mandibular alveolar ridge - An In-vivo study. J Int Oral Health. 2014 Apr;6(2):45-54. Epub 2014 Apr 26.
PubMed 24876702Choi S, Kim S, Chang JS. The Neutral Zone Approach with CAD-CAM Record Bases. J Prosthodont. 2022 Jul;31(6):459-463. doi: 10.1111/jopr.13502. Epub 2022 Mar 24.
PubMed 35271758
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Analysis of Denture Space Confines and Patient's Satisfaction for Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges.(Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05895292
- Acronym / sponsor ID
- CAD/CAM / FDASU-RecIR012316
- Conditions
- Denture, Complete
- Keywords
- CAD/CAM, Denture, Complete, Patient Satisfaction, Dental Impression Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 8 Jun 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 within-subject randomized clinical trial that will compare and evaluate patients' satisfaction and digitally analyze denture space Confines. Group I: CAD/CAM. (computer-aided design/computer-aided manufacturing) Conventional complete dentures will be designed based on the bone support concept, Group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. 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
This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: CAD/CAM conventional complete dentures will be designed based on the bone support concept, group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The study will be carried out on twelve completely edentulous patients exhibiting advanced residual ridge resorption, each patient will receive two sets of complete dentures in a random sequence, and each set of CDs will be worn for at least eight weeks after the last recall visit before assessments. Upon delivery of the second set of CDs, the first set will be withheld from the patient. For each denture set, patient satisfaction will be rated using a patient denture assessment PDA questionnaire that will be assessed via a Likert scale, the obtained scores will be used to compare the two denture types. Also by using special digital software, a comparison between group I and II virtual complete denture images will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept. | Experimental | Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.The patient will be provided by a complete removable denture designed according to bone-support concept to restore his missing teeth which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks. |
| CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. | Active comparator | Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.The patient will be provided with a complete removable denture designed according to the neutral-concept to restore his missing teeth, which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
- The age of patients ranges from 50 to 80 years old.
- Patients with a resorbed mandibular ridge.
- Patients with a Class I maxillo-mandibular relationship
- Patients with adequate inter-arch space.
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 |
|---|---|---|
| CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.The patients will receive complete removable dentures designed based on the bone-support concept and digitally manufactured using a milling machine. | Device | CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept. |
| CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machine | Device | CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. |
Primary outcome
Digital Analysis and Comparison of Denture Space Confines for CAD/CAM Dentures Based on the bone-support concept Versus based on the neutral-zone concept Restoring Mandibular Resorbed Ridges using "Medit compare" digital software.
Time frame: before manufacturing of complete removable denture
comparing the position of the neutral zone to the software-designed anatomical denture confines using "Medit compare" digital software (Medit design, Medit Compare (V1.2), Seoul, South Korea). Average values of facio-lingual deviations between the two dentures in the premolar and molar regions, as well as the anterior region, will be calculated in millimeters, yielding five measurements for each patient's denture sets. Color maps for dimensional deviations of the overall as well as specified surfaces for both dentures revealing the qualitative 3D differences between them will be obtained. Measuring procedures will be similar, as recommended by the manufacturer and all will be performed by the same digital professional operator.
1 secondary outcome
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures
Time frame: three 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 19 Sep 2024.
- Background: PubMed 24876702Bhorgonde D, Nandakumar K, Khurana PR, Kumari VS, Reddy MS, Siddique S. An evaluation of the position of the neutral zone in relation to the crest of mandibular alveolar ridge - An In-vivo study. J Int Oral Health. 2014 Apr;6(2):45-54. Epub 2014 Apr 26.
- Background: PubMed 35271758Choi S, Kim S, Chang JS. The Neutral Zone Approach with CAD-CAM Record Bases. J Prosthodont. 2022 Jul;31(6):459-463. doi: 10.1111/jopr.13502. Epub 2022 Mar 24.
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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 CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept. and CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept. 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 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: finished, as of the sponsor's last update on 19 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?
Digital Analysis and Comparison of Denture Space Confines for CAD/CAM Dentures Based on the bone-support concept Versus based on the neutral-zone concept Restoring Mandibular Resorbed Ridges using "Medit compare" digital software. (time frame: before manufacturing of complete removable denture). 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 NCT05895292, 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 19 Sep 2024.