EdentulismNCT06752642
CD vs IOD Opposing Mandibular IOD : Bone Height Changes of the Premaxilla
A study testing Implant overdenture in people with Edentulism, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate bone resorption of the anterior region of maxillary arch. The main questions it aims to answer are: Does implants assisting maxillary complete denture enhance stability, retention and mastication of the patient ? Does implants assisting maxillary complete denture reduce… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Edentulism
- What is being tested?
- Implant overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to 15 Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General good health without any systemic diseases affecting bone resorption such as uncontrolled diabetes or osteoporosis. This was confirmed through taking medical history and clinical examination by a physician.
- Having angel's class I maxillo-mandibular relationships.
- Presence of sufficient bone quality and quantity in the anterior region of maxilla and mandible which allow inserting implants of at least 3.75 mm diameter and 10 mm length. This was verified by Preoperative low dose Cone Beam (C.T) d) Presence of sufficient restorative space (a minimum of 15 mm must be available from the mucosa covering the crest of the residual ridge to the proposed occlusal plane), this was confirmed by tentative jaw relation.
- Having maladaptive maxillary conventional complete denture.
Who cannot join
- Uncontrolled systemic diseases such as: uncontrolled hypertension, or uncontrolled cardiovascular disease
- metabolic disorders such as diabetes mellitus
- Patients with compromised immune systems as (Long term immunosuppressant and corticosteroid drug
- TMJ dis orders and neuromuscular diseases
- Patient with abnormal habits as clenching and bruxism, Smoking patient, Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Denture Versus Implant Overdenture Opposing Mandibular Implant Overdenture: Residual Alveolar Bone Height Changes of the Premaxilla
The goal of this clinical trial is to evaluate bone resorption of the anterior region of maxillary arch. The main questions it aims to answer are:
Does implants assisting maxillary complete denture enhance stability, retention and mastication of the patient ?
Does implants assisting maxillary complete denture reduce bone resorption in the anterior region of maxilla ?
Participants will:
- receive 2 implants with attachments assisting their maxillary complete denture
- Visit the clinic once every 6 months for checkups and tests
Read the detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation.
The trial will include A total of twenty male adult patients unsatisfied with their maxillary complete denture seeking to enhance their mastication and esthetics. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.
each patient will receive 2 implants with attachments to assist their maxillary complete denture then follow up every 6 months for checkups.
No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation
- Conditions
- Edentulism
- Being tested
- Implant overdenture
- Keywords
- overdenture, implants, maxilla, edentulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant overdentureProcedure or surgery
patients received implant overdenture
| Study group | Role | What they receive |
|---|---|---|
| maxillary conventional denture and mandibular implant overdenture | Active comparator | Participants have maxillary complete denture opposing mandibular implant overdenture Receives: Procedure: Implant overdenture |
| maxillary and mandibular implant overdenture | Active comparator | Participants have maxillary implant overdenture opposing mandibular implant overdenture Receives: Procedure: Implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height changes
assessment of bone height changes in the premaxilla
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start10 Jan 2022
- Primary completion15 Sep 2023
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moataz Mohamed Soliman Elezaby, Mansoura University
- Investigators
- Moataz M. Elezaby, PhD student, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752642
- Sponsor's protocol ID
- M01030821
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Denture Versus Implant Overdenture Opposing Mandibular Implant Overdenture: Residual Alveolar Bone Height Changes of the Premaxilla
- ClinicalTrials.gov ID
- NCT06752642
- Acronym / sponsor ID
- M01030821
- Conditions
- Edentulism
- Keywords
- overdenture, implants, maxilla, edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 31 Dec 2024 (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 evaluate bone resorption of the anterior region of maxillary arch. The main questions it aims to answer are:
Does implants assisting maxillary complete denture enhance stability, retention and mastication of the patient ?
Does implants assisting maxillary complete denture reduce bone resorption in the anterior region of maxilla ?
Participants will:
- receive 2 implants with attachments assisting their maxillary complete denture
- Visit the clinic once every 6 months for checkups and tests
Detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation.
The trial will include A total of twenty male adult patients unsatisfied with their maxillary complete denture seeking to enhance their mastication and esthetics. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.
each patient will receive 2 implants with attachments to assist their maxillary complete denture then follow up every 6 months for checkups.
No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maxillary conventional denture and mandibular implant overdenture | Active comparator | Procedure: Implant overdentureParticipants have maxillary complete denture opposing mandibular implant overdenture |
| maxillary and mandibular implant overdenture | Active comparator | Procedure: Implant overdentureParticipants have maxillary implant overdenture opposing mandibular implant overdenture |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- General good health without any systemic diseases affecting bone resorption such as uncontrolled diabetes or osteoporosis. This was confirmed through taking medical history and clinical examination by a physician.
- Having angel's class I maxillo-mandibular relationships.
- Presence of sufficient bone quality and quantity in the anterior region of maxilla and mandible which allow inserting implants of at least 3.75 mm diameter and 10 mm length. This was verified by Preoperative low dose Cone Beam (C.T) d) Presence of sufficient restorative space (a minimum of 15 mm must be available from the mucosa covering the crest of the residual ridge to the proposed occlusal plane), this was confirmed by tentative jaw relation.
- Having maladaptive maxillary conventional complete denture.
Key exclusion criteria (5 listed)
- Uncontrolled systemic diseases such as: uncontrolled hypertension, or uncontrolled cardiovascular disease
- metabolic disorders such as diabetes mellitus
- Patients with compromised immune systems as (Long term immunosuppressant and corticosteroid drug
- TMJ dis orders and neuromuscular diseases
- Patient with abnormal habits as clenching and bruxism, Smoking patient, Uncooperative 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 |
|---|---|---|
| Implant overdenturepatients received implant overdenture | Procedure or surgery | maxillary and mandibular implant overdenture, maxillary conventional denture and mandibular implant overdenture |
Primary outcome
bone height changes
Time frame: 18 months
assessment of bone height changes in the premaxilla
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 31 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Edentulism
Active, not recruiting
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Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
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Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
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Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
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The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
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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.
Moataz M. Elezaby, PhD student principal investigator
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 Edentulism, 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 4 inclusion and 5 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 31 Dec 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?
bone height changes (time frame: 18 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 31 Dec 2024.