The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- The Implant Stability Quotient
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group A : Patients received vitamin D and calcium supplementation during the healing period
- 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.
- Daily intake of Maxical calcium carbonate tablets (600 mg elemental calcium) for six months.
Intervention: Patients received vitamin D and calcium supplementation during the healing period (Procedure)
Group B: Patients have not received any nutritional supplementation during the healing period.
Intervention: Patients have not received any nutritional supplementation during the healing period. (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- DXA Scan(pre-operative, and 6 Months post-operative)
- Vitamin D serum levels(Pre-operative, and 6 Months post-operative)
- Calcium Serum Level(Pre-operative, and 6 Months post-operative)
Investigators
Mostafa Sharkawy
Resident at Oral and Maxillofacial Surgery
Al-Azhar University