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

Endodontic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109417
• Other study ID #: 00010556
• Status: Completed
• Phase: N/A
• Start date: November 24, 2014
• Est. completion date: October 12, 2017

Study information

• Verified date: September 2019
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 12, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy patients.

2. Selected tooth with previous root canal therapy failure and in need of endodontic surgery.

3. Existence of a periapical radiographic lesion surrounding the root canal treated tooth, of size = 1 cm.

4. Healthy periodontal condition (probing depth, mobility & epithelial attachment level are all within normal range).

Exclusion Criteria:

1. Leaking coronal restoration.

2. Periodontal ligament breakdown and presence of apicomarginal defects.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease

Intervention

Procedure:
• osteotomy filled with PRP-gel and covered with PRP-biomembrane

• osteotomy site following the surgical intervention was left empty

Locations

Country	Name	City	State
Egypt	faculty of dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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