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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

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

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

NCT ID

NCT04842188

First Posted

April 8, 2021

Last Updated

June 20, 2021

Sponsor

Kafrelsheikh University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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Furcation Treatment With L-PRF and aPDT

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