Bone LossNCT06055842
Different Implant Positions for Implant Retained Mandibular Overdenture
A study testing over-denture in people with Bone Loss, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will aim to evaluate the effect of two different implant positions, lateral incisors, and canine areas, on anterior and posterior ridge resorption and bone remodeling after different periods of denture insertion. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- over-denture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Aug 2023to 1 Dec 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mandibular two implants retained overdenture opposing complete edentulous maxillary arch,
- attended the previous follow-up recalls with previous CBCT examination.
Who cannot join
- Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study on the Effect of Different Implant Positions for Implant Retained Mandibular Overdenture: Radiographic Evaluation of the Circumferential Bone Level and Bone Remodeling in the Anterior and Posterior Mandible
This study will aim to evaluate the effect of two different implant positions, lateral incisors, and canine areas, on anterior and posterior ridge resorption and bone remodeling after different periods of denture insertion.
Read the detailed description
Twelve patients will be recruited from a previous study (14), having two-implant mandibular overdentures. Patients recalled from the database set of the clinic of the Removable Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be grouped based on the position of the two implants.
All patients will be informed about all prosthetic procedures that will be done. Also, they will sign the consent form of the ethical committee of the faculty of dentistry, at Mansoura University.
All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will excluded from the study Patients will be divided into two groups Group A (6 patients): Patients having two mandibular implants in lateral incisor positions.
Group B (6 patients): Patients having two mandibular implants in canine positions.
- Conditions
- Bone Loss
- Being tested
- over-denture
- Keywords
- implant, overdenture
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
over-dentureOther
implant retained overdenture prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| lateral incisor group | Active comparator | Patients having two mandibular implants in lateral incisor positions. Receives: Other: over-denture |
| canine group | Active comparator | Patients having two mandibular implants in canine positions Receives: Other: over-denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant survival rate
index
Measured: 5 years
circumferential bone loss
peri-implant bone changes in mm
Measured: 5 years
posterior bone changes
bone loss in mm
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start23 Aug 2023
- Primary completion12 Oct 2023
- Study completion1 Dec 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 Bone LossStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khloud Ezzat, Mansoura University
- Investigators
- Khloud Ezzat, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055842
- Sponsor's protocol ID
- M0108023RP
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mourad KE, Emera RMK, Habib A. Effect of different implant positions for two implant-retained mandibular overdenture: a retrospective 5-years radiographic evaluation of the circumferential peri-implant bone loss and posterior ridge resorptive changes. BMC Oral Health. 2024 Sep 30;24(1):1161. doi: 10.1186/s12903-024-04871-w.
PubMed 39350107
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Effect of Different Implant Positions for Implant Retained Mandibular Overdenture: Radiographic Evaluation of the Circumferential Bone Level and Bone Remodeling in the Anterior and Posterior Mandible
- ClinicalTrials.gov ID
- NCT06055842
- Acronym / sponsor ID
- M0108023RP
- Conditions
- Bone Loss
- Keywords
- implant, overdenture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 Sep 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 will aim to evaluate the effect of two different implant positions, lateral incisors, and canine areas, on anterior and posterior ridge resorption and bone remodeling after different periods of denture insertion.
Detailed description
Twelve patients will be recruited from a previous study (14), having two-implant mandibular overdentures. Patients recalled from the database set of the clinic of the Removable Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be grouped based on the position of the two implants.
All patients will be informed about all prosthetic procedures that will be done. Also, they will sign the consent form of the ethical committee of the faculty of dentistry, at Mansoura University.
All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will excluded from the study Patients will be divided into two groups Group A (6 patients): Patients having two mandibular implants in lateral incisor positions.
Group B (6 patients): Patients having two mandibular implants in canine positions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral incisor group | Active comparator | Other: over-denturePatients having two mandibular implants in lateral incisor positions. |
| canine group | Active comparator | Other: over-denturePatients having two mandibular implants in canine positions |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mandibular two implants retained overdenture opposing complete edentulous maxillary arch,
- attended the previous follow-up recalls with previous CBCT examination.
Key exclusion criteria (1 listed)
- Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.
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 |
|---|---|---|
| over-dentureimplant retained overdenture prosthesis. | Other | canine group, lateral incisor group |
Primary outcome
implant survival rate
Time frame: 5 years
index
circumferential bone loss
Time frame: 5 years
peri-implant bone changes in mm
posterior bone changes
Time frame: 5 years
bone loss in mm
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 7 Jan 2025.
- Derived from this study: PubMed 39350107Mourad KE, Emera RMK, Habib A. Effect of different implant positions for two implant-retained mandibular overdenture: a retrospective 5-years radiographic evaluation of the circumferential peri-implant bone loss and posterior ridge resorptive changes. BMC Oral Health. 2024 Sep 30;24(1):1161. doi: 10.1186/s12903-024-04871-w.
- 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.
Khloud Ezzat principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing over-denture in people with Bone Loss, 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 2 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 7 Jan 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?
implant survival rate (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT06055842, 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 7 Jan 2025.