DefinePK

Research Objective

To evaluate the efficacy of adjuvant therapy with Concentrated Growth Factor (CGF) along with xenograft and autograft in mandible fractures, in terms of bone density gain and healing over a period of 6 months.

Methodology

This was a Randomized Clinical Trial conducted at a public sector tertiary care hospital in Karachi from May 2019 to July 2022. Patients (aged 18-40) with mandible fractures requiring bone grafts due to non-union, delayed union, or mal-union, and having a fracture gap size between >5mm and <5cm, were included. Patients with bone disorders or medically compromised conditions were excluded. Participants were divided into three groups (20 patients each) using a simple random sampling envelope method:
* Group A: Mandibular surgery using autograft alone.
* Group B: Autograft combined with CGF.
* Group C: Xenograft combined with CGF.
CGF was prepared following standardized guidelines using an automated centrifuge. Surgical procedures involved general anesthesia, aseptic measures, incision, full-thickness flap reflection, fracture cleaning, fixation with mini-plates, and application of the assigned graft modality, followed by soft tissue closure. Post-operative monitoring involved serial cone-beam computed tomography (CBCT) scans at the 4th and 6th months. A radiology specialist evaluated grey levels on CBCT scans to quantify Bone Mineral Density (BMD) using Planmeca Romexis 6 software.

Methodology Flowchart

                        graph TD
    A[Patient Recruitment] --> B[Obtain Informed Consent];
    B --> C[Systemic History & Pre-operative Radiographs];
    C --> D[RandomizationEnvelope Method];
    D --> E1[Group A: Autograft Alone];
    D --> E2[Group B: Autograft + CGF];
    D --> E3[Group C: Xenograft + CGF];
    E1 --> F[Surgical Procedure];
    E2 --> F;
    E3 --> F;
    F --> G[Post-operative CBCT Scan at 4 Months];
    G --> H[Post-operative CBCT Scan at 6 Months];
    H --> I[Bone Density Evaluation by Radiology Specialist];
    I --> J[Results & Conclusion];                    

Discussion

The study confirmed that CGF, when combined with either autograft or xenograft, significantly enhances bone density in mandibular fractures compared to autograft alone. The similar outcomes between CGF with autograft and CGF with xenograft highlight xenograft as a viable alternative, reducing donor site morbidity associated with autograft harvesting. The use of CBCT for 3D bone mineral density assessment was supported by previous studies. Demographic findings showed a male predominance and RTAs as the primary cause, consistent with global trends. The results align with other research on the osteogenic potential of CGF and platelet-derived growth factors in bone regeneration. Limitations include applicability to larger bone defects (>10mm) and the assessment being limited to numeric bone mineral density.

Key Findings

All three groups showed a significant increase in bone bulk formation and bone density between the 4th and 6th months post-operatively (p < 0.001), indicating the effectiveness of all treatment modalities. Intergroup comparison revealed that bone density was comparatively higher in groups B (autograft + CGF) and C (xenograft + CGF) than in group A (autograft alone). The mean difference in bone density over 6 months was similar for Group A (-229.2 HU) and Group B (-227.7 HU), while Group C showed a slightly greater mean difference of -237.9 HU. No statistically significant difference was found between Group B and Group C, suggesting similar outcomes for both CGF combinations. Symphysis fractures were the most common (50-60%), and road traffic accidents were the leading cause (65-75%).

Conclusion

Bone mineral density increased significantly in all three groups from the 4th to the 6th month post-operatively, confirming that all modalities promote bone density and accelerate healing. Groups B (autograft + CGF) and C (xenograft + CGF) exhibited higher bone density compared to Group A (autograft alone), with comparable results between groups B and C. Therefore, using xenograft with CGF is a viable and preferable alternative to autograft, as it avoids donor site morbidity and patient inconvenience.

Fact Check

1. Study Duration: The trial was conducted from May 2019 to July 2022, taking "around 3 years to complete." This is confirmed in the Methodology section.
2. Statistical Significance: The results showed a "significant increase in bone bulk formation across all three groups... (p < 0.001)." This p-value is consistently reported in the Results and Abstract.
3. Female Participation: "only one female who voluntarily agreed to participate was included." This is stated in the Methodology and Demographic Data sections.

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