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Completed

NCT Number: NCT06673485

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alazhar University

Asyut, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. DXA Scan

    Time frame: pre-operative, and 6 Months post-operative

    DXA scan was carried out to T-score. minimum is - 4 and maximum is 1. the more T-score, the better the bone density.

  2. Vitamin D serum levels

    Time frame: Pre-operative, and 6 Months post-operative

    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.

  3. Calcium Serum Level

    Time frame: Pre-operative, and 6 Months post-operative

    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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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