Occlusal AnalysisNCT06995547
Digital Workflow Versus Functional Pick-up Techniques of Two- Implant Retained Mandibular Overdentures
A study testing implant overdenture in people with Occlusal Analysis, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this clinical trial] is to learn if digital pick up can affect occlusal forces on teeth in completely edentulous patients restored with digital complete overdenturs. The main question it aims to answer is: Researchers will compare digital vs functional pick-up techniques to see if it affects occlusal… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Occlusal Analysis
- What is being tested?
- implant overdenture
- 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
- 15 Sep 2022to 25 Mar 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely edentulous, healthy firm mucosa without any remaining roots or jaw cysts. Maxillomandibular Angel's class I relationship with sufficient restorative space (minimum of 8.5 mm measured by using putty index). Sufficient residual alveolar bone quantity and quality class 1-3
Who cannot join
- Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases like rheumatoid arthritis, hyperparathyroidism, uncontrolled diabetes mellitus, severe osteoporosis or cancer were excluded from the study. Also, patients with recent organ transplants, long-term corticosteroid use, radiotherapy, uncooperative patients with psychiatric disorders, heavy smokers, poor oral hygiene, and parafunctional habits were excluded
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial] is to learn if digital pick up can affect occlusal forces on teeth in completely edentulous patients restored with digital complete overdenturs. The main question it aims to answer is:
Researchers will compare digital vs functional pick-up techniques to see if it affects occlusal force.
Participants will be asked to bite on digital articulating paper (occlusense).
- Conditions
- Occlusal Analysis
- Being tested
- implant overdenture
- Keywords
- CAD-CAM, implant, locator attachment, occlusense.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant overdentureDevice
Each patient will be receive two dental implants for overdenture fixation
| Study group | Role | What they receive |
|---|---|---|
| functional pick up Group | Active comparator | Not described Receives: Device: implant overdenture |
| digital pick up Group | Active comparator | Not described Receives: Device: implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
occlusal force analysis
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start15 Sep 2022
- Primary completion2 Feb 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusal AnalysisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya ebrahim elsayed elsayed elnagar, Mansoura University
- Investigators
- Abdallah mohamed Ibrahim, assistant professor, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995547
- Sponsor's protocol ID
- M36080622
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Workflow Versus Functional Pick-up Techniques of Two- Implant Retained Mandibular Overdentures
- ClinicalTrials.gov ID
- NCT06995547
- Acronym / sponsor ID
- M36080622
- Conditions
- Occlusal Analysis
- Keywords
- CAD-CAM, implant, locator attachment, occlusense.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 29 May 2025 (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 goal of this clinical trial] is to learn if digital pick up can affect occlusal forces on teeth in completely edentulous patients restored with digital complete overdenturs. The main question it aims to answer is:
Researchers will compare digital vs functional pick-up techniques to see if it affects occlusal force.
Participants will be asked to bite on digital articulating paper (occlusense).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional pick up Group | Active comparator | Device: implant overdenture |
| digital pick up Group | Active comparator | Device: implant overdenture |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- completely edentulous, healthy firm mucosa without any remaining roots or jaw cysts. Maxillomandibular Angel's class I relationship with sufficient restorative space (minimum of 8.5 mm measured by using putty index). Sufficient residual alveolar bone quantity and quality class 1-3
Key exclusion criteria (1 listed)
- Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases like rheumatoid arthritis, hyperparathyroidism, uncontrolled diabetes mellitus, severe osteoporosis or cancer were excluded from the study. Also, patients with recent organ transplants, long-term corticosteroid use, radiotherapy, uncooperative patients with psychiatric disorders, heavy smokers, poor oral hygiene, and parafunctional habits were excluded
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 |
|---|---|---|
| implant overdentureEach patient will be receive two dental implants for overdenture fixation | Device | digital pick up Group, functional pick up Group |
Primary outcome
occlusal force analysis
Time frame: twelve 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 29 May 2025.
- 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.
Abdallah mohamed Ibrahim, assistant professor study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant overdenture in people with Occlusal Analysis, 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 29 May 2025. 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?
occlusal force analysis (time frame: twelve 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 29 May 2025.