Complete EdentulismNCT07080164
Evaluation of Oral Health-Related Quality of Life In Patients With Conventional Complete Dentures Versus Mini-Implant Retained Overdentures: A Randomized Clinical Trial
A study testing mini implant retained overdenture in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.
Trial summary
Mini-implants have emerged as a practical and less invasive solution for the rehabilitation of edentulous mandibles, offering reduced surgical complexity, lower cost, and faster healing compared to conventional implants. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- mini implant retained overdenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous mandible for a minimum period of 6 months Adult patients capable of understanding, cooperating, and providing informed consent Sufficient bone volume and interarch space in the anterior mandible to accommodate two mini-implants and overdenture attachments Good general health permitting minor oral surgical procedures Willingness to undergo follow-up visits and comply with study protocols
Who cannot join
- Systemic medical conditions that preclude implant surgery, including poorly controlled chronic diseases such as diabetes mellitus or disorders affecting bone metabolism.
- Patients taking medications known to affect bone metabolism (e.g., bisphosphonates, corticosteroids) Patients with physical or mental disabilities that impair oral hygiene maintenance or compliance Heavy smokers (>10 cigarettes/day) Individuals unable or unwilling to attend scheduled follow-up or participate throughout the study duration Patients who can receive standard implants with no anatomical limitations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Oral and Dental Medicine Cairo University
Cairo, 002
magdy zarea, 01144252034
Yasmien EE Abdelrauof, master, 01124253523, yasmien_emad@dentistry.cu.edu.eg
About this study
Mini-implants have emerged as a practical and less invasive solution for the rehabilitation of edentulous mandibles, offering reduced surgical complexity, lower cost, and faster healing compared to conventional implants. These advantages make them especially suitable for elderly patients or those with systemic health concerns or limited bone volume. Despite their growing clinical use, evidence from well-designed randomized controlled trials evaluating the impact of mini-implant-retained overdentures on patients' oral health-related quality of life (OHRQoL) is still scarce. Establishing this evidence is crucial for guiding treatment decisions in resource-constrained settings and improving the standard of care for edentulous individuals. This research aims to provide high-quality data on the effectiveness of mini-implants in improving OHRQoL, as measured by OHIP-14, compared to conventional dentures./
- Conditions
- Complete Edentulism
- Being tested
- mini implant retained overdenture
- Keywords
- mini-implant overdentures ,OHRQoL ,RCT, Minimally invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini implant retained overdentureOther
mini implant retained overdenture
| Study group | Role | What they receive |
|---|---|---|
| conventional dentures | Active comparator | Not described Receives: Other: mini implant retained overdenture |
| mini implant retained overdenture | Experimental | mini implant retained overdenture Receives: Other: mini implant retained overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHRQoL
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmien Emad Eldeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080164
- Sponsor's protocol ID
- 1-1-2
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Health-Related Quality of Life In Patients With Conventional Complete Dentures Versus Mini-Implant Retained Overdentures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07080164
- Acronym / sponsor ID
- 1-1-2
- Conditions
- Complete Edentulism
- Keywords
- mini-implant overdentures ,OHRQoL ,RCT, Minimally invasive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 23 Jul 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.
Mini-implants have emerged as a practical and less invasive solution for the rehabilitation of edentulous mandibles, offering reduced surgical complexity, lower cost, and faster healing compared to conventional implants. These advantages make them especially suitable for elderly patients or those with systemic health concerns or limited bone volume. Despite their growing clinical use, evidence from well-designed randomized controlled trials evaluating the impact of mini-implant-retained overdentures on patients' oral health-related quality of life (OHRQoL) is still scarce. Establishing this evidence is crucial for guiding treatment decisions in resource-constrained settings and improving the standard of care for edentulous individuals. This research aims to provide high-quality data on the effectiveness of mini-implants in improving OHRQoL, as measured by OHIP-14, compared to conventional dentures./
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional dentures | Active comparator | Other: mini implant retained overdenture |
| mini implant retained overdenture | Experimental | Other: mini implant retained overdenturemini implant retained overdenture |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completely edentulous mandible for a minimum period of 6 months Adult patients capable of understanding, cooperating, and providing informed consent Sufficient bone volume and interarch space in the anterior mandible to accommodate two mini-implants and overdenture attachments Good general health permitting minor oral surgical procedures Willingness to undergo follow-up visits and comply with study protocols
Key exclusion criteria (2 listed)
- Systemic medical conditions that preclude implant surgery, including poorly controlled chronic diseases such as diabetes mellitus or disorders affecting bone metabolism.
- Patients taking medications known to affect bone metabolism (e.g., bisphosphonates, corticosteroids) Patients with physical or mental disabilities that impair oral hygiene maintenance or compliance Heavy smokers (>10 cigarettes/day) Individuals unable or unwilling to attend scheduled follow-up or participate throughout the study duration Patients who can receive standard implants with no anatomical limitations
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 |
|---|---|---|
| mini implant retained overdenturemini implant retained overdenture | Other | conventional dentures, mini implant retained overdenture |
Primary outcome
OHRQoL
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini implant retained overdenture in people with Complete Edentulism, 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 23 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OHRQoL (time frame: 1 year). 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 23 Jul 2025.