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

A

Alexandria University

Status

Completed

Conditions

Endodontic Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04109417
00010556

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

20 to 45 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

osteotomy filled with PRP-gel and covered with PRP-biomembrane
Experimental group
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
Treatment:
Procedure: osteotomy filled with PRP-gel and covered with PRP-biomembrane
osteotomy site left empty
Sham Comparator group
Description:
osteotomy site following the surgical intervention was left empty
Treatment:
Procedure: osteotomy site following the surgical intervention was left empty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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