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

Primary Purpose

Endodontic Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
osteotomy filled with PRP-gel and covered with PRP-biomembrane
osteotomy site following the surgical intervention was left empty
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Disease

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • faculty of dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

osteotomy filled with PRP-gel and covered with PRP-biomembrane

osteotomy site left empty

Arm Description

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

osteotomy site following the surgical intervention was left empty

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
September 25, 2019
Last Updated
September 27, 2019
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04109417
Brief Title
Effect of Platelet-Rich Plasma Biomembrane on Enhancing Bone Regeneration Following Endodontic Surgery
Official Title
Effect of Platelet-Rich Plasma Biomembrane on Enhancing Bone Regeneration Following Endodontic Surgery:A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 24, 2014 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
October 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
osteotomy filled with PRP-gel and covered with PRP-biomembrane
Arm Type
Experimental
Arm Description
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
Arm Title
osteotomy site left empty
Arm Type
Sham Comparator
Arm Description
osteotomy site following the surgical intervention was left empty
Intervention Type
Procedure
Intervention Name(s)
osteotomy filled with PRP-gel and covered with PRP-biomembrane
Intervention Type
Procedure
Intervention Name(s)
osteotomy site following the surgical intervention was left empty
Primary Outcome Measure Information:
Title
degree of periapical inflammation using periapical index (PAI)
Description
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
Title
degree of periapical inflammation using periapical index (PAI)
Description
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
Title
degree of periapical inflammation using periapical index (PAI)
Description
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
Title
degree of periapical inflammation using periapical index (PAI)
Description
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
Title
degree of periapical inflammation using periapical index (PAI)
Description
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
Title
degree of periapical inflammation using periapical index (PAI)
Description
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
Title
degree of periapical inflammation using CBCT periapical index (CBCTPAI)
Description
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
Title
degree of periapical inflammation using CBCT periapical index (CBCTPAI)
Description
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
Title
changes in bone mineral density of lesions in CBCT images
Description
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
Title
changes in bone mineral density of lesions in CBCT images
Description
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
Secondary Outcome Measure Information:
Title
Platelet count in whole blood sample and in platelet rich plasma concentrate
Description
Platelet count in whole blood sample and in platelet rich plasma concentrate is assessed to detect fold increase in platelet count
Time Frame
baseline
Title
concentration of Platelet-derived growth factor (PDGF) in the prepared PRP
Description
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
Title
concentration of vascular endothelial growth factors (VEGF) in the prepared PRP
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
salma genena, PhD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt

12. IPD Sharing Statement

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

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