Bone ResorptionNCT06206005
Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes
An observational study of Bone Resorption, run by Mansoura University at 1 site in Egypt.
Trial summary
Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Observational study
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Dec 2023to 5 Aug 2024
- Phase
- Observational
- 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 55 to 65 years
- All sexes
- Adult, Older adult
Study population: 20 participants at least.
Who may be able to join
- Patients with edentulous maxilla and mandible for at least 12 months.
- Patients have problems with mandibular denture retention and stability.
- Patients with a mandibular bone height measured on a panoramic x-ray between 15 and 25 mm at the mandibular symphysis region.
Who cannot join
- Patients who did not receive implants at the department clinic.
- Patients with more or less than 4 implants in the mandible.
- Patients with well controlled diabetics.
- Patients with relative contraindications, such as a history of parafunctional habits, daily smokers of more than 10 cigarettes, or alcoholism.
- Patients who have previously received head and neck radiation therapy; furthermore, patients receiving intravenous bisphosphonates, chemotherapy, or psychological disorders could jeopardize their cooperation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammed ELSawy
Al Mansurah, 12345
Mohammed Elsawy, PhD, 00201061314522, Dr_sawy@windowslive.com
Doaa A. Mewafy, PhD, 00201061133971, Doaamowafy@mans.edu.eg
About this study
Official title: Clinical and Radiographic Outcomes Around Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes: A Long-term Retrospective Preliminary Study
Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.
Read the detailed description
Chronic hyperglycemia is considered as a typical risk-factor that causes soft tissue inflammation and bone loss around natural teeth and implants. One possible explanation for this mechanism is that chronic hyperglycemia has the propensity to increase the levels of accumulated glycation end products (AGEs) in the serum and oral tissues that accelerates the production of proinflammatory cytokines that induce bone destruction around natural teeth and implants. However, it is relevant to indicate that dental implants in chronic hyperglycemia under ideal glycemic conditions can successfully osseointegrate and show predictable outcomes over long durations in both diabetic and non-diabetic patients.
Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.
- Conditions
- Bone Resorption
- Being tested
- Observational study
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
evaluate implant survival, peri-implant outcome of 4 implant retained mandibular OVD after 10 years of function.
| Study group | Role | What they receive |
|---|---|---|
| Group1 with Haemoglobin A1c ≤6.5% | This group represents a well-controlled type 2 Diabetics mellitus. Receives: Other: Observational study | |
| Group 2 with Haemoglobin A1c >6.5% | This group represents a poorly controlled type 2 Diabetics mellitus. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone loss around implants
amount of bone loss which appears on a periapical radiograph
Measured: This is a retrospective study, Measurement will be performed after implants being in service by 10 years
Secondary outcomes (1)
Probing depth
By using a plastic periodontal probe to measure the probing depth around the implants
Measured: This is a retrospective study, Measurement will be performed after implants being in service by 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start4 Dec 2023
- Primary completion5 May 2024 (estimated)
- Study completion5 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, Mohamed Elsawy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206005
- Sponsor's protocol ID
- A03012023RP
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD is upon request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes Around Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes: A Long-term Retrospective Preliminary Study
- ClinicalTrials.gov ID
- NCT06206005
- Acronym / sponsor ID
- A03012023RP
- Conditions
- Bone Resorption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 5 May 2024 (estimated)
- Study completion
- 5 Aug 2024 (estimated)
- First posted
- 16 Jan 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.
Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.
Detailed description
Chronic hyperglycemia is considered as a typical risk-factor that causes soft tissue inflammation and bone loss around natural teeth and implants. One possible explanation for this mechanism is that chronic hyperglycemia has the propensity to increase the levels of accumulated glycation end products (AGEs) in the serum and oral tissues that accelerates the production of proinflammatory cytokines that induce bone destruction around natural teeth and implants. However, it is relevant to indicate that dental implants in chronic hyperglycemia under ideal glycemic conditions can successfully osseointegrate and show predictable outcomes over long durations in both diabetic and non-diabetic patients.
Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 with Haemoglobin A1c ≤6.5% | – | Other: Observational studyThis group represents a well-controlled type 2 Diabetics mellitus. |
| Group 2 with Haemoglobin A1c >6.5% | – | Other: Observational studyThis group represents a poorly controlled type 2 Diabetics mellitus. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 20 participants at least.
Key inclusion criteria (3 listed)
- Patients with edentulous maxilla and mandible for at least 12 months.
- Patients have problems with mandibular denture retention and stability.
- Patients with a mandibular bone height measured on a panoramic x-ray between 15 and 25 mm at the mandibular symphysis region.
Key exclusion criteria (5 listed)
- Patients who did not receive implants at the department clinic.
- Patients with more or less than 4 implants in the mandible.
- Patients with well controlled diabetics.
- Patients with relative contraindications, such as a history of parafunctional habits, daily smokers of more than 10 cigarettes, or alcoholism.
- Patients who have previously received head and neck radiation therapy; furthermore, patients receiving intravenous bisphosphonates, chemotherapy, or psychological disorders could jeopardize their cooperation.
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 |
|---|---|---|
| Observational studyevaluate implant survival, peri-implant outcome of 4 implant retained mandibular OVD after 10 years of function. | Other | Group 2 with Haemoglobin A1c >6.5%, Group1 with Haemoglobin A1c ≤6.5% |
Primary outcome
Crestal bone loss around implants
Time frame: This is a retrospective study, Measurement will be performed after implants being in service by 10 years
amount of bone loss which appears on a periapical radiograph
1 secondary outcome
Probing depth
Time frame: This is a retrospective study, Measurement will be performed after implants being in service by 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No. The IPD is upon request from the corresponding author
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Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Osteopenia
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Resorption, 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 3 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: status not confirmed, as of the sponsor's last update on 26 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Elsawy, PhD (00201061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone loss around implants (time frame: This is a retrospective study, Measurement will be performed after implants being in service by 10 years). 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 26 Jan 2024.