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

NCT04109417 | Completed

• 1 other identifier: 00010556
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Disease

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Platelet count in whole blood sample and in platelet rich plasma concentrate

  baseline

• concentration of Platelet-derived growth factor (PDGF) in the prepared PRP

  baseline

• concentration of vascular endothelial growth factors (VEGF) in the prepared PRP

  baseline

Study Arms (2)

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

EXPERIMENTAL

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 left empty

SHAM COMPARATOR

osteotomy site following the surgical intervention was left empty

Procedure: osteotomy site following the surgical intervention was left empty

Interventions

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

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

osteotomy site following the surgical intervention was left empty PROCEDURE

osteotomy site left empty

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Leaking coronal restoration.
• Periodontal ligament breakdown and presence of apicomarginal defects.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

faculty of dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• salma genena, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Endodontics, Conservative Dentistry Department

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 30, 2019
• Study Start: November 24, 2014
• Primary Completion: September 12, 2017
• Study Completion: October 12, 2017
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

EG (1)