Vitamin D DeficiencyNCT04906161
Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
An observational study of Vitamin D Deficiency and Dental Implant Failure Nos, run by Ain Shams University at 2 sites in Egypt.
Trial summary
In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Vitamin D Deficiency, Dental Implant Failure Nos
- What is being tested?
- Vitamin D and calcium levels
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Jan 2021to 30 Jun 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Multicenter study on systemically free participants that had a dental implant within the last 6 months using the same implant system, preoperative planning techniques, surgical protocol (minimal invasive implant concept), post surgical protocol and excluding any cases with intrasurgical difficulties and complications.
Who may be able to join
- Missing single tooth
- Systemically free
- Average body mass index
Who cannot join
- Systemic conditions
- Bad oral hygiene
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams University
Cairo, Abbassia, 11566
Doaa Adel-Khattab, PhD, +201006814258, dr.doaa.adel-khattab@dent.asu.edu.eg
Mohamed S El-Mofty, PhD, +201001431000, mofty@dr.com
- Recruiting
Doaa Khattab
Cairo, Abbassia, 11566
About this study
Official title: Correlation Between Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D.
Read the detailed description
Osseointegration is a complex phenomenon and depends on many factors; some are related to the implant (material, macroscopic design, and implant surface), others to the surgical-prosthetic protocol (surgical technique, loading conditions, and time), and others to the patient (quantity/quality of bone at the receiving site and the host response)
All these observations would suggest the existence of specific patient-related risk factors such as vitamin D deficiency in the blood, could play an important role in the occurrence of early dental implant failures (EDIFs), but unfortunately are neglected by the dental literature.
In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D. Therefore we are including patients with early implant failure during the year 2020 using the same implant (material, macroscopic design, and implant surface), surgical-prosthetic protocol (surgical technique, loading conditions, and time)
The study will be performed into 15 male and 15 female participants that had dental implant placement in the last 3 months. An informed consent will be signed with the patient with full detail on the study.
The situation of the implant will be categorized into either successful or failed dental implant.
Medical history and lifestyle information will be obtained by questionnaire. Levels of serum vitamin D will be collected from participants
Statistical analysis will correlate between vitamin D and early implant failure.
- Conditions
- Vitamin D Deficiency, Dental Implant Failure Nos
- Being tested
- Vitamin D and calcium levels
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and calcium levelsDiagnostic test
Mini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France)
| Study group | Role | What they receive |
|---|---|---|
| Successful dental implant | Patients showed a successful implant placement with no complications before loading Receives: Diagnostic Test: Vitamin D and calcium levels | |
| Early dental implant failure | Early complications and failure of dental implant before loading Receives: Diagnostic Test: Vitamin D and calcium levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant success with normal serum vitamin D level
Implant stability with no further radiographic bone loss following bone remodeling with successful prosthetic part
Measured: 6 months
Early implant failure with deficient serum vitamin D level
Mobile extruded implant with radiographic bone loss and peri-implant pathosis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start20 Jan 2021
- Primary completion20 Jul 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Adel Salah Khattab, Ain Shams University
- Investigators
- Bassem E Abd ElMoneim Hussein, MDs, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906161
- Sponsor's protocol ID
- 1388
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 28 May 2021
- Results posted
- 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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
- ClinicalTrials.gov ID
- NCT04906161
- Acronym / sponsor ID
- 1388
- Conditions
- Vitamin D Deficiency, Dental Implant Failure Nos
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 28 May 2021 (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.
In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D.
Detailed description
Osseointegration is a complex phenomenon and depends on many factors; some are related to the implant (material, macroscopic design, and implant surface), others to the surgical-prosthetic protocol (surgical technique, loading conditions, and time), and others to the patient (quantity/quality of bone at the receiving site and the host response)
All these observations would suggest the existence of specific patient-related risk factors such as vitamin D deficiency in the blood, could play an important role in the occurrence of early dental implant failures (EDIFs), but unfortunately are neglected by the dental literature.
In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D. Therefore we are including patients with early implant failure during the year 2020 using the same implant (material, macroscopic design, and implant surface), surgical-prosthetic protocol (surgical technique, loading conditions, and time)
The study will be performed into 15 male and 15 female participants that had dental implant placement in the last 3 months. An informed consent will be signed with the patient with full detail on the study.
The situation of the implant will be categorized into either successful or failed dental implant.
Medical history and lifestyle information will be obtained by questionnaire. Levels of serum vitamin D will be collected from participants
Statistical analysis will correlate between vitamin D and early implant failure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful dental implant | – | Diagnostic Test: Vitamin D and calcium levelsPatients showed a successful implant placement with no complications before loading |
| Early dental implant failure | – | Diagnostic Test: Vitamin D and calcium levelsEarly complications and failure of dental implant before loading |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Multicenter study on systemically free participants that had a dental implant within the last 6 months using the same implant system, preoperative planning techniques, surgical protocol (minimal invasive implant concept), post surgical protocol and excluding any cases with intrasurgical difficulties and complications.
Key inclusion criteria (3 listed)
- Missing single tooth
- Systemically free
- Average body mass index
Key exclusion criteria (2 listed)
- Systemic conditions
- Bad oral hygiene
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 |
|---|---|---|
| Vitamin D and calcium levelsMini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France) | Diagnostic test | Early dental implant failure, Successful dental implant |
Primary outcome
Implant success with normal serum vitamin D level
Time frame: 6 months
Implant stability with no further radiographic bone loss following bone remodeling with successful prosthetic part
Early implant failure with deficient serum vitamin D level
Time frame: 6 months
Mobile extruded implant with radiographic bone loss and peri-implant pathosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- 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.
Bassem E Abd ElMoneim Hussein, MDs principal investigator
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Dental Implant Failure Nos, run by Ain Shams University at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Doaa Adel-Khattab, PhD (+201006814258, dr.doaa.adel-khattab@dent.sasu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success with normal serum vitamin D level (time frame: 6 months). 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 28 May 2021.