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Furcation Treatment With L-PRF and aPDT

Primary Purpose

Furcation Defects

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
L-PRF with aPDT
L-PRF
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects focused on measuring platelet rich fibrin, photodynamic therapy

Eligibility Criteria

32 Years - 48 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Grade II furcation involvement
  • age range 18- 50 years
  • 3 mm or more vertical probing depth

Exclusion Criteria:

  • systemic disease
  • abnormal clotting and bleeding
  • smokers,
  • root caries or restoration
  • Grade II mobility
  • periapical lesions

Sites / Locations

  • faculty of dentistry, kafrelsheikh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

L-PRF

L-PRF with aPDT

Arm Description

Leukocyte platelet rich fibrin as a sole graft material in class II furcation

Leukocyte platelet rich fibrin combined with antibacterial photodynamic therapy in class II furcation

Outcomes

Primary Outcome Measures

Clinical evaluation of Vertical clinical attachment level VCAL
using periodontal probe in mm
clinical evaluation of vertical pocket depth VPD
using periodontal probe in mm
clinical evaluation of furcation horizontal component FHC
using periodontal probe in mm
clinical evaluation of gingival recession REC
using periodontal probe in mm

Secondary Outcome Measures

Full Information

First Posted
April 8, 2021
Last Updated
June 20, 2021
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT04842188
Brief Title
Furcation Treatment With L-PRF and aPDT
Official Title
Evaluation of Leukocyte Platelet Rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Furcation Involvement: Randomised Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To treat grade II periodontally diseased furcation areas Leukocyte-Platelet Rich Fibrin (L-PRF) combined with antimicrobial Photo-Dynamic Therapy (a-PDT) was used.
Detailed Description
randomized, triple-blinded study (patient, clinician and biostatistician). Twenty-four patients with Grade II furcation involvement were recruited in this study. Control group only received L-PRF, while study group used a combination of L-PRF and aPDT Attachment level, pocket depth, horizontal component and gingival recession, also radiographic Bone depth, width, height and volume were were recorded at baseline and postoperatively after 6 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects
Keywords
platelet rich fibrin, photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-PRF
Arm Type
Active Comparator
Arm Description
Leukocyte platelet rich fibrin as a sole graft material in class II furcation
Arm Title
L-PRF with aPDT
Arm Type
Active Comparator
Arm Description
Leukocyte platelet rich fibrin combined with antibacterial photodynamic therapy in class II furcation
Intervention Type
Procedure
Intervention Name(s)
L-PRF with aPDT
Intervention Description
surgical open flap debridement followed by L-PRF with aPDT
Intervention Type
Procedure
Intervention Name(s)
L-PRF
Intervention Description
surgical open flap debridement followed by L-PRF alone
Primary Outcome Measure Information:
Title
Clinical evaluation of Vertical clinical attachment level VCAL
Description
using periodontal probe in mm
Time Frame
6 months
Title
clinical evaluation of vertical pocket depth VPD
Description
using periodontal probe in mm
Time Frame
6 months
Title
clinical evaluation of furcation horizontal component FHC
Description
using periodontal probe in mm
Time Frame
6 months
Title
clinical evaluation of gingival recession REC
Description
using periodontal probe in mm
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Grade II furcation involvement age range 18- 50 years 3 mm or more vertical probing depth Exclusion Criteria: systemic disease abnormal clotting and bleeding smokers, root caries or restoration Grade II mobility periapical lesions
Facility Information:
Facility Name
faculty of dentistry, kafrelsheikh University
City
Kafr Ash Shaykh
ZIP/Postal Code
214312
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Furcation Treatment With L-PRF and aPDT

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