Prosthesis DurabilityNCT06080815
Impact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion
A study testing CAD/CAM Complete denture in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
This within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- CAD/CAM Complete denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2022to 7 Mar 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture
Who cannot join
- diabetic and heavy smoker patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mandibular 4-Implant Overdenture Base Construction Techniques on Assessment of Occlusion With Digital Occlusion Analysis System (Within Patient Study)
This within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense
- Conditions
- Prosthesis Durability
- Being tested
- CAD/CAM Complete denture
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM Complete dentureDevice
four implant-supported CAD/CAM complete overdenture
| Study group | Role | What they receive |
|---|---|---|
| Group I: patients receive maxillary complete denture opposed to conventional mandibular overdenture | Active comparator | Not described Receives: Device: CAD/CAM Complete denture |
| Group II: patients receive maxillary complete denture opposed CAD/CAM overdenture | Active comparator | Not described Receives: Device: CAD/CAM Complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
digital occlusal analysis
occlusion was analyzed by occlusense device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start10 May 2022
- Primary completion15 Dec 2022
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis DurabilityStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- According to the construction technique for the maxillary complete denture and mandibular overdentures, the patients will be classified randomly and equally into two groups. Group I: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with conventional method. Group II: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with CAD/CAM milling.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080815
- Sponsor's protocol ID
- 05201021
- Status last verified
- Sep 2023
- First submitted
- 8 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelghany AA, Fouad MM, Emera RMK, Askar O, Yaseen AAM. Impact of mandibular 4-implant overdenture base construction techniques on assessment of occlusion with digital occlusion analysis system (clinical crossover study). BMC Oral Health. 2025 May 30;25(1):853. doi: 10.1186/s12903-025-06228-3.
PubMed 40448094
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mandibular 4-Implant Overdenture Base Construction Techniques on Assessment of Occlusion With Digital Occlusion Analysis System (Within Patient Study)
- ClinicalTrials.gov ID
- NCT06080815
- Acronym / sponsor ID
- 05201021
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 12 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 within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- According to the construction technique for the maxillary complete denture and mandibular overdentures, the patients will be classified randomly and equally into two groups. Group I: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with conventional method. Group II: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with CAD/CAM milling.
| Arm | Type | Receives |
|---|---|---|
| Group I: patients receive maxillary complete denture opposed to conventional mandibular overdenture | Active comparator | Device: CAD/CAM Complete denture |
| Group II: patients receive maxillary complete denture opposed CAD/CAM overdenture | Active comparator | Device: CAD/CAM Complete denture |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture
Key exclusion criteria (1 listed)
- diabetic and heavy smoker 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 |
|---|---|---|
| CAD/CAM Complete denturefour implant-supported CAD/CAM complete overdenture | Device | Group I: patients receive maxillary complete denture opposed to conventional mandibular overdenture, Group II: patients receive maxillary complete denture opposed CAD/CAM overdenture |
Primary outcome
digital occlusal analysis
Time frame: 6 months
occlusion was analyzed by occlusense device
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 12 Oct 2023.
- Derived from this study: PubMed 40448094Abdelghany AA, Fouad MM, Emera RMK, Askar O, Yaseen AAM. Impact of mandibular 4-implant overdenture base construction techniques on assessment of occlusion with digital occlusion analysis system (clinical crossover study). BMC Oral Health. 2025 May 30;25(1):853. doi: 10.1186/s12903-025-06228-3.
- Individual participant dataSharing planned: No
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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 Complete denture in people with Prosthesis Durability, run by Mansoura 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 1 inclusion and 1 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 12 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?
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 occlusal analysis (time frame: 6 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 NCT06080815, which also lists 1 linked publication.
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 12 Oct 2023.