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The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla

The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla: a Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06673485
Enrollment
12
Registered
2024-11-05
Start date
2021-10-02
Completion date
2023-03-01
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant

Keywords

maxillary sinus augmentation, Sinus graft, Internal Sinus lifting, Allogenic bone graft

Brief 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.

Interventions

PROCEDUREPatients received vitamin D and calcium 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, 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.

PROCEDUREPatients 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.

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patient with residual bone height from 5 : 8 . * Patient with insufficient Vit D levels. * Patient with D4 bone density.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The Implant Stability QuotientImmediate post-operative, and 6 Months post-operativeThe 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.

Secondary

MeasureTime frameDescription
DXA Scanpre-operative, and 6 Months post-operativeDXA scan was carried out to T-score. minimum is - 4 and maximum is 1. the more T-score, the better the bone density.
Vitamin D serum levelsPre-operative, and 6 Months post-operativeVitamin 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.
Calcium Serum LevelPre-operative, and 6 Months post-operativeCalcium 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026