Clinical trial NCT04109417: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Disease
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: degree of periapical inflammation using periapical index (PAI)
timeFrame: baseline
measure: degree of periapical inflammation using periapical index (PAI)
timeFrame: 3 months
measure: degree of periapical inflammation using periapical index (PAI)
timeFrame: 6 months
measure: degree of periapical inflammation using periapical index (PAI)
timeFrame: 9 months
measure: degree of periapical inflammation using periapical index (PAI)
timeFrame: 12 months
measure: degree of periapical inflammation using periapical index (PAI)
timeFrame: 18 months
measure: degree of periapical inflammation using CBCT periapical index (CBCTPAI)
timeFrame: baseline
measure: degree of periapical inflammation using CBCT periapical index (CBCTPAI)
timeFrame: 18 months
measure: changes in bone mineral density of lesions in CBCT images
timeFrame: baseline
measure: changes in bone mineral density of lesions in CBCT images
timeFrame: 18 months
Secondary outcomes:
measure: Platelet count in whole blood sample and in platelet rich plasma concentrate
timeFrame: baseline
measure: concentration of Platelet-derived growth factor (PDGF) in the prepared PRP
timeFrame: baseline
measure: concentration of vascular endothelial growth factors (VEGF) in the prepared PRP
timeFrame: baseline
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: faculty of dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: salma genena, PhD
role: PRINCIPAL_INVESTIGATOR
References: