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

NCT ID: NCT04109417

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-24

Study Completion Date

2017-10-12

Brief Summary

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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

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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.

Conditions

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Endodontic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

osteotomy site left empty

osteotomy site following the surgical intervention was left empty

Group Type SHAM_COMPARATOR

osteotomy site following the surgical intervention was left empty

Intervention Type PROCEDURE

Interventions

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

Intervention Type PROCEDURE

osteotomy site following the surgical intervention was left empty

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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salma genena

Lecturer of Endodontics, Conservative Dentistry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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salma genena, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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faculty of dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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00010556

Identifier Type: -

Identifier Source: org_study_id