Dental ImplantNCT06673485
The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla
A study testing Patients received vitamin D and calcium supplementation during the healing period and Patients have not received any nutritional supplementation during the healing period. in people with Dental Implant, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of Vit D and Calcium administration on allogragt bone maturation radiographically and histomorphometercally in maxillary sinus augmentation in cases of D4 bone density. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Patients received vitamin D and calcium supplementation during the healing period and Patients have not received any nutritional supplementation during the healing period.
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2021to 1 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with residual bone height from 5 : 8 .
- Patient with insufficient Vit D levels.
- Patient with D4 bone density.
Who cannot join
- Patients that have aproporiate amount of Ca and Vit D.
- Sinus pathology that precludes routine sinus augmentation.
- Heavy smookers patients.
- Systemic diseases that interfere with bone maturion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla: a Randomized Clinical Trial
The aim of the study is to evaluate the effect of Vit D and Calcium administration on allogragt bone maturation radiographically and histomorphometercally in maxillary sinus augmentation in cases of D4 bone density.
- Conditions
- Dental Implant
- Being tested
- Patients received vitamin D and calcium supplementation during the healing period, Patients have not received any nutritional supplementation during the healing period.
- Keywords
- maxillary sinus augmentation, Sinus graft, Internal Sinus lifting, Allogenic bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients received vitamin D and calcium supplementation during the healing periodProcedure or surgery
The proposed implant site and adjacent tissues were disinfected using betadine mouthwash, and standard infiltration anesthesia was administered both buccally and palatally. A paracrestal incision was then made over the intended implant location, and the mucoperiosteal flap was elevated to expose the underlying bone. Subsequently, an osteotomy was prepared using a 2.0 mm pilot drill, maintaining irrigation with sterile saline. The osseodensification protocol was employed with Densah burs in increasing diameters (2 mm, 3 mm, 4 mm) under copious irrigation. Throughout the osteotomy preparation, implant angulation was regularly checked using a paralling pin. Upon encountering haptic feedback, pressure was modulated to achieve the desired depth. The implant was then installed using a surgical handpiece, and the final insertion torque was recorded using a torque wrench, ensuring successful placement.
During the healing period, the patients recieved Vitamin D and Calcium Supplements.
Patients have not received any nutritional supplementation during the healing period.Procedure or surgery
The proposed implant site and adjacent tissues were disinfected using betadine mouthwash, and standard infiltration anesthesia was administered both buccally and palatally. A paracrestal incision was then made over the intended implant location, and the mucoperiosteal flap was elevated to expose the underlying bone. Subsequently, an osteotomy was prepared using a 2.0 mm pilot drill while maintaining irrigation with sterile saline. The osseodensification protocol was employed with Densah burs in increasing diameters (2 mm, 3 mm, 4 mm) under copious irrigation. Throughout the osteotomy preparation, implant angulation was regularly checked using a paraling pin. Upon encountering haptic feedback, pressure was modulated to achieve the desired depth. The implant was then installed using a surgical handpiece, and the final insertion torque was recorded using a torque wrench, ensuring successful placement. During the healing period, the patients did not receive vitamin or calcium supplements.
| Study group | Role | What they receive |
|---|---|---|
| Group A : Patients received vitamin D and calcium supplementation during the healing period | Experimental | 1. Monthly intramuscular injections of vitamin D3 (300,000 I.U.) for three months, concurrent with six months of oral Maxical vitamin D supplementation post-implant placement.
2. Daily intake of Maxical calcium carbonate tablets (600 mg elemental calcium) for six months. Receives: Procedure: Patients received vitamin D and calcium supplementation during the healing period |
| Group B: Patients have not received any nutritional supplementation during the healing period. | Experimental | Not described Receives: Procedure: Patients have not received any nutritional supplementation during the healing period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Implant Stability Quotient
The Implant Stability Quotient (ISQ) will be assessed using the Osstell device, which provides a stability score ranging from 0 ISQ to 100 ISQ. Higher ISQ values indicate greater implant stability, with 0 ISQ representing the lowest stability and 100 ISQ the highest. This measure allows for consistent, objective assessment of implant stability across time points.
Measured: Immediate post-operative, and 6 Months post-operative
Secondary outcomes (3)
DXA Scan
DXA scan was carried out to T-score. minimum is - 4 and maximum is 1. the more T-score, the better the bone density.
Measured: pre-operative, and 6 Months post-operative
Vitamin D serum levels
Vitamin D serum levels (nanograms per milliliter (ng/ml)) will be represented as values, with higher values indicating a better vitamin D status. This measurement provides an objective assessment of vitamin D levels across participants.
Measured: Pre-operative, and 6 Months post-operative
Calcium Serum Level
Calcium serum levels (milligrams per deciliter (mg/dl)) will be measured, with higher values indicating better calcium status within the physiological range. This measurement provides an objective assessment of calcium levels across participants, allowing for consistent evaluation of calcium status.
Measured: Pre-operative, and 6 Months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start2 Oct 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Sharkawy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673485
- Sponsor's protocol ID
- AUAREC20210100-06
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06673485
- Acronym / sponsor ID
- AUAREC20210100-06
- Conditions
- Dental Implant
- Keywords
- maxillary sinus augmentation, Sinus graft, Internal Sinus lifting, Allogenic bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 5 Nov 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 aim of the study is to evaluate the effect of Vit D and Calcium administration on allogragt bone maturation radiographically and histomorphometercally in maxillary sinus augmentation in cases of D4 bone density.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Patients received vitamin D and calcium supplementation during the healing period | Experimental | Procedure: Patients received vitamin D and calcium supplementation during the healing period1. Monthly intramuscular injections of vitamin D3 (300,000 I.U.) for three months, concurrent with six months of oral Maxical vitamin D supplementation post-implant placement. 2. Daily intake of Maxical calcium carbonate tablets (600 mg elemental calcium) for six months. |
| Group B: Patients have not received any nutritional supplementation during the healing period. | Experimental | Procedure: Patients have not received any nutritional supplementation during the healing period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with residual bone height from 5 : 8 .
- Patient with insufficient Vit D levels.
- Patient with D4 bone density.
Key exclusion criteria (4 listed)
- Patients that have aproporiate amount of Ca and Vit D.
- Sinus pathology that precludes routine sinus augmentation.
- Heavy smookers patients.
- Systemic diseases that interfere with bone maturion.
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 |
|---|---|---|
| Patients received vitamin D and calcium supplementation during the healing periodThe proposed implant site and adjacent tissues were disinfected using betadine mouthwash, and standard infiltration anesthesia was administered both buccally and palatally. A paracrestal incision was then made over the intended implant location, and the mucoperiosteal flap was elevated to expose the underlying bone. Subsequently, an osteotomy was prepared using a 2.0 mm pilot drill, maintaining irrigation with sterile saline. The osseodensification protocol was employed with Densah burs in increasing diameters (2 mm, 3 mm, 4 mm) under copious irrigation. Throughout the osteotomy preparation, implant angulation was regularly checked using a paralling pin. Upon encountering haptic feedback, pressure was modulated to achieve the desired depth. The implant was then installed using a surgical handpiece, and the final insertion torque was recorded using a torque wrench, ensuring successful placement. During the healing period, the patients recieved Vitamin D and Calcium Supplements. | Procedure or surgery | Group A : Patients received vitamin D and calcium supplementation during the healing period |
| Patients have not received any nutritional supplementation during the healing period.The proposed implant site and adjacent tissues were disinfected using betadine mouthwash, and standard infiltration anesthesia was administered both buccally and palatally. A paracrestal incision was then made over the intended implant location, and the mucoperiosteal flap was elevated to expose the underlying bone. Subsequently, an osteotomy was prepared using a 2.0 mm pilot drill while maintaining irrigation with sterile saline. The osseodensification protocol was employed with Densah burs in increasing diameters (2 mm, 3 mm, 4 mm) under copious irrigation. Throughout the osteotomy preparation, implant angulation was regularly checked using a paraling pin. Upon encountering haptic feedback, pressure was modulated to achieve the desired depth. The implant was then installed using a surgical handpiece, and the final insertion torque was recorded using a torque wrench, ensuring successful placement. During the healing period, the patients did not receive vitamin or calcium supplements. | Procedure or surgery | Group B: Patients have not received any nutritional supplementation during the healing period. |
Primary outcome
The Implant Stability Quotient
Time frame: Immediate post-operative, and 6 Months post-operative
The Implant Stability Quotient (ISQ) will be assessed using the Osstell device, which provides a stability score ranging from 0 ISQ to 100 ISQ. Higher ISQ values indicate greater implant stability, with 0 ISQ representing the lowest stability and 100 ISQ the highest. This measure allows for consistent, objective assessment of implant stability across time points.
3 secondary outcomes
DXA Scan
Time frame: pre-operative, and 6 Months post-operative
Vitamin D serum levels
Time frame: Pre-operative, and 6 Months post-operative
Calcium Serum Level
Time frame: Pre-operative, and 6 Months post-operative
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 5 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients received vitamin D and calcium supplementation during the healing period and Patients have not received any nutritional supplementation during the healing period. in people with Dental Implant, run by Al-Azhar 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 4 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 5 Nov 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?
The Implant Stability Quotient (time frame: Immediate post-operative, and 6 Months post-operative). 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 5 Nov 2024.