An interventional study of osteotomy filled with PRP-gel and covered with PRP-biomembrane and osteotomy site following the surgical intervention was left empty in Endodontic Disease, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
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.
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.
125 studies on the registry are indexed under Dental Pulp Diseases; 38 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 103 interventional studies indexed under Dental Pulp Diseases.
Browse Dental Pulp Diseases studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
osteotomy site following the surgical intervention was left empty
Procedure: osteotomy site following the surgical intervention was left empty
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
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
Time frame: 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
Time frame: 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
Time frame: baseline
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Alexandria University