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

NCT06673485 | Completed

• 1 other identifier: AUAREC20210100-06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

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.

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

Procedure: Patients have not received any nutritional supplementation during the healing period.

Interventions

Patients received vitamin D and calcium supplementation during the healing period PROCEDURE

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.

Group A : Patients received vitamin D and calcium supplementation during the healing period

Patients have not received any nutritional supplementation during the healing period. PROCEDURE

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.

Group B: Patients have not received any nutritional supplementation during the healing period.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar University

Asyut, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: November 5, 2024
• Study Start: October 2, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-10

Locations

EG (1)