Effect of Platelet-Rich Plasma Biomembrane on Enhancing Bone Regeneration Following Endodontic Surgery

Study Overview
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Brief Summary
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This study was conducted to evaluate clinical and radiographical outcome of using a standardized platelet-rich plasma (PRP) biomembrane following endodontic surgery and its correlation with the growth factors content in this concentrate.

Detailed Description
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15 healthy patients of both genders, between 20 and 45 years of age, presenting with 22 anterior/premolar teeth in need of endodontic surgery were recruited. Teeth presented with failed non-surgical root canal therapy and periapical radiolucency of ≥ 1cm in size. Patients were randomly divided following surgery into two groups, with 11 teeth each.

Official Title
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Effect of Platelet-Rich Plasma Biomembrane on Enhancing Bone Regeneration Following Endodontic Surgery:A Prospective Randomized Clinical Trial

Conditions
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Endodontic Disease

Intervention / Treatment
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* Procedure: osteotomy filled with PRP-gel and covered with PRP-biomembrane
* Procedure: osteotomy site following the surgical intervention was left empty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients. Selected tooth with previous root canal therapy failure and in need of endodontic surgery. Existence of a periapical radiographic lesion surrounding the root canal treated tooth, of size ≥ 1 cm. Healthy periodontal condition (probing depth, mobility & epithelial attachment level are all within normal range). Exclusion Criteria: Leaking coronal restoration. Periodontal ligament breakdown and presence of apicomarginal defects.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: osteotomy filled with PRP-gel and covered with PRP-biomembrane<br>the defect was filled with the previously activated autologous Platelet-rich plasma (PRP) gel and its supernatant. The site was then externally covered with the prepared bio-membrane composed of activated PRP which acted as an adjunct to the mucoperiosteal flap to stimulate tissue regeneration | Procedure: osteotomy filled with PRP-gel and covered with PRP-biomembrane<br> <br> |
| Sham Comparator: osteotomy site left empty<br>osteotomy site following the surgical intervention was left empty | Procedure: osteotomy site following the surgical intervention was left empty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of periapical inflammation using periapical index (PAI) | The PAI is a 5-point scale radiographic interpretation designed to determine the absence, presence, or transformation of a disease state. Each of the roots was categorized as: (1) Normal periapical structure; (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features. Each category used in the PAI represents a step on an ordinal scale of registration of periapical infection. | baseline | 
| degree of periapical inflammation using periapical index (PAI) | The PAI is a 5-point scale radiographic interpretation designed to determine the absence, presence, or transformation of a disease state. Each of the roots was categorized as: (1) Normal periapical structure; (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features. Each category used in the PAI represents a step on an ordinal scale of registration of periapical infection. | 3 months | 
| degree of periapical inflammation using periapical index (PAI) | The PAI is a 5-point scale radiographic interpretation designed to determine the absence, presence, or transformation of a disease state. Each of the roots was categorized as: (1) Normal periapical structure; (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features. Each category used in the PAI represents a step on an ordinal scale of registration of periapical infection. | 6 months | 
| degree of periapical inflammation using periapical index (PAI) | The PAI is a 5-point scale radiographic interpretation designed to determine the absence, presence, or transformation of a disease state. Each of the roots was categorized as: (1) Normal periapical structure; (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features. Each category used in the PAI represents a step on an ordinal scale of registration of periapical infection. | 9 months | 
| degree of periapical inflammation using periapical index (PAI) | The PAI is a 5-point scale radiographic interpretation designed to determine the absence, presence, or transformation of a disease state. Each of the roots was categorized as: (1) Normal periapical structure; (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features. Each category used in the PAI represents a step on an ordinal scale of registration of periapical infection. | 12 months | 
| degree of periapical inflammation using periapical index (PAI) | The PAI is a 5-point scale radiographic interpretation designed to determine the absence, presence, or transformation of a disease state. Each of the roots was categorized as: (1) Normal periapical structure; (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features. Each category used in the PAI represents a step on an ordinal scale of registration of periapical infection. | 18 months | 
| degree of periapical inflammation using CBCT periapical index (CBCTPAI) | CBCTPAI is a 6-point (0 -5) scoring system .The scores were calculated by analysis of the lesion in 3 dimensions, with CT slices being obtained in mesiodistal, buccopalatal, and diagonal directions. The score was determined by the largest extension of the lesion. The measurement of lesion depth in a CBCT image added the variables expansion of cortical bone (E) and destruction of cortical bone (D) usually detected starting from score 2. | baseline | 
| degree of periapical inflammation using CBCT periapical index (CBCTPAI) | CBCTPAI is a 6-point (0 -5) scoring system .The scores were calculated by analysis of the lesion in 3 dimensions, with CT slices being obtained in mesiodistal, buccopalatal, and diagonal directions. The score was determined by the largest extension of the lesion. The measurement of lesion depth in a CBCT image added the variables expansion of cortical bone (E) and destruction of cortical bone (D) usually detected starting from score 2. | 18 months | 
| changes in bone mineral density of lesions in CBCT images | region of interest measurements were made by the same operator in the sagittal view to provide consistency throughout the study protocol (baseline and at a 12 to 18 months post-operative interval). ROI was selected through drawing a polyline pattern that enabled us to include all the confines of the lesion (On Demand 3D® viewing software was used to obtain a mean grey level using the region of interest (ROI) polyline tool in sagittal plane images. The images of each CBCT scan were captured using the print screen button and exported into a Microsoft Word document as a record. | baseline | 
| changes in bone mineral density of lesions in CBCT images | region of interest measurements were made by the same operator in the sagittal view to provide consistency throughout the study protocol (baseline and at a 12 to 18 months post-operative interval). ROI was selected through drawing a polyline pattern that enabled us to include all the confines of the lesion (On Demand 3D® viewing software was used to obtain a mean grey level using the region of interest (ROI) polyline tool in sagittal plane images. The images of each CBCT scan were captured using the print screen button and exported into a Microsoft Word document as a record. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count in whole blood sample and in platelet rich plasma concentrate | Platelet count in whole blood sample and in platelet rich plasma concentrate is assessed to detect fold increase in platelet count | baseline | 
| concentration of Platelet-derived growth factor (PDGF) in the prepared PRP | concentration of Platelet-derived growth factor (PDGF) in the prepared PRP was quantified using ELISA methods (R&D Center, Tokyo, Japan). The analyses were then performed as instructed by manufacturer | baseline | 
| concentration of vascular endothelial growth factors (VEGF) in the prepared PRP | Concentrations of VEGF growth factors in PRP was quantified using ELISA methods (R&D Center, Tokyo, Japan). The analyses were then performed as instructed by manufacturer | baseline |