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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04109417
Enrollment
15
Registered
2019-09-30
Start date
2014-11-24
Completion date
2017-10-12
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontic Disease

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.

Interventions

PROCEDUREosteotomy filled with PRP-gel and covered with PRP-biomembrane
PROCEDUREosteotomy site following the surgical intervention was left empty

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
degree of periapical inflammation using periapical index (PAI)baselineThe 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)baselineCBCTPAI 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 imagesbaselineregion 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

MeasureTime frameDescription
concentration of Platelet-derived growth factor (PDGF) in the prepared PRPbaselineconcentration 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 PRPbaselineConcentrations 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
Platelet count in whole blood sample and in platelet rich plasma concentratebaselinePlatelet count in whole blood sample and in platelet rich plasma concentrate is assessed to detect fold increase in platelet count

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026