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

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 Overview

• Status: Completed
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: Patients received vitamin D and calcium supplementation during the healing period; Procedure: Patients have not received any nutritional supplementation during the healing period.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Alazhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Patients 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.
Experimental: Group B: Patients have not received any nutritional supplementation during the healing period.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediate post-operative, and 6 Months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Pre-operative, and 6 Months post-operative

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: maxillary sinus augmentation; Sinus graft; Internal Sinus lifting; Allogenic bone graft
• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Calcium; Vitamin D
• Other Study ID Numbers: AUAREC20210100-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No