Implant Site ReactionNCT05974215
Peri Implant Marginal Bone Height and Bone Density
A study testing assessment of change in bone height by cone beam computed tomography in people with Implant Site Reaction, run by Menatallah Mohamed Elhotieby at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of mandibular implant supported removable overdenture on bone height and density and compare it with implant supported fixed overdenture in single mandibular overdenture. Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- assessment of change in bone height by cone beam computed tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 5 Jul 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Non-smoker Patients
- Highly cooperative and motivated patients.
- Patients Systemically free from any immunosuppressive diseases.
Who cannot join
- Diabetic, hypertensive, cancer patients.
- Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions and foreign bodies.
- Patients with temporo-mandibular joint disorders and bad oral habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri Implant Marginal Bone Height and Density Supporting Different Prosthesis Restoring Single Edentulous Mandible
This study aims to evaluate the effect of mandibular implant supported removable overdenture on bone height and density and compare it with implant supported fixed overdenture in single mandibular overdenture.
Read the detailed description
In this study 10 patients will be selected following inclusion and exclusion criteria. In each group 5 patients (each patient will receive 6 implants) will be divided randomly into two groups.
Group I patients will receive mandibular implant supported removable overdenture, while Group II will receive mandibular implant supported fixed overdenture.
All patients will be given the usual home care instructions about wearing and caring of dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with denture brush and mild soap will be required. Measurements of Bone height and Bone density will be obtained by using Cone Beam Computed Tomography (CBCT).
Measurements will be obtained at denture insertion, after 1 month and after 3 months.
- Conditions
- Implant Site Reaction
- Being tested
- assessment of change in bone height by cone beam computed tomography
- Keywords
- Bone height, Bone density, Implant supported
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of change in bone height by cone beam computed tomographyDevice
bone height was measured at 1 ,30 ,90 days after denture insertion
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | patients received mandibular implant supported removable overdenture Receives: Device: assessment of change in bone height by cone beam computed tomography |
| group 2 | Active comparator | patients received mandibular implant supported fixed overdenture Receives: Device: assessment of change in bone height by cone beam computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change of bone height around dental implants
bone height was assessed by cone beam computed tomography
Measured: on the first day, on 30th day, 90th day
assessment of change of bone density around dental implants
bone density was assessed by cone beam computed tomography
Measured: on the first day, on 30th day, 90th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Apr 2023
- Primary completion1 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Parallel groups
- Model description
- group 1 mandibular implant supported overdenture group 2 mandibular implant supported fixed overdenture
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menatallah Mohamed Elhotieby
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menatallah Mohamed Elhotieby, National Research Centre, Egypt
- Investigators
- Menatallah Elhotieby, Researcher, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974215
- Sponsor's protocol ID
- 1431022023
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri Implant Marginal Bone Height and Density Supporting Different Prosthesis Restoring Single Edentulous Mandible
- ClinicalTrials.gov ID
- NCT05974215
- Acronym / sponsor ID
- 1431022023
- Conditions
- Implant Site Reaction
- Keywords
- Bone height, Bone density, Implant supported
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Menatallah Mohamed ElhotiebyUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 3 Aug 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 aims to evaluate the effect of mandibular implant supported removable overdenture on bone height and density and compare it with implant supported fixed overdenture in single mandibular overdenture.
Detailed description
In this study 10 patients will be selected following inclusion and exclusion criteria. In each group 5 patients (each patient will receive 6 implants) will be divided randomly into two groups.
Group I patients will receive mandibular implant supported removable overdenture, while Group II will receive mandibular implant supported fixed overdenture.
All patients will be given the usual home care instructions about wearing and caring of dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with denture brush and mild soap will be required. Measurements of Bone height and Bone density will be obtained by using Cone Beam Computed Tomography (CBCT).
Measurements will be obtained at denture insertion, after 1 month and after 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- group 1 mandibular implant supported overdenture group 2 mandibular implant supported fixed overdenture
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Device: assessment of change in bone height by cone beam computed tomographypatients received mandibular implant supported removable overdenture |
| group 2 | Active comparator | Device: assessment of change in bone height by cone beam computed tomographypatients received mandibular implant supported fixed overdenture |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smoker Patients
- Highly cooperative and motivated patients.
- Patients Systemically free from any immunosuppressive diseases.
Key exclusion criteria (3 listed)
- Diabetic, hypertensive, cancer patients.
- Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions and foreign bodies.
- Patients with temporo-mandibular joint disorders and bad oral habits.
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 |
|---|---|---|
| assessment of change in bone height by cone beam computed tomographybone height was measured at 1 ,30 ,90 days after denture insertion | Device | group 1, group 2 |
Primary outcome
assessment of change of bone height around dental implants
Time frame: on the first day, on 30th day, 90th day
bone height was assessed by cone beam computed tomography
assessment of change of bone density around dental implants
Time frame: on the first day, on 30th day, 90th day
bone density was assessed by cone beam computed tomography
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 8 Aug 2023.
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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.
Menatallah Elhotieby, Researcher principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of change in bone height by cone beam computed tomography in people with Implant Site Reaction, run by Menatallah Mohamed Elhotieby 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 3 inclusion and 3 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 8 Aug 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?
assessment of change of bone height around dental implants (time frame: on the first day, on 30th day, 90th day). The study lists 2 primary outcomes in all. 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 8 Aug 2023.