NCT04842188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

April 8, 2021

Last Update Submit

June 20, 2021

Conditions

Furcation Defects

Keywords

platelet rich fibrinphotodynamic therapy

Outcome Measures

Primary Outcomes (4)

  • Clinical evaluation of Vertical clinical attachment level VCAL

    using periodontal probe in mm

    6 months

  • clinical evaluation of vertical pocket depth VPD

    using periodontal probe in mm

    6 months

  • clinical evaluation of furcation horizontal component FHC

    using periodontal probe in mm

    6 months

  • clinical evaluation of gingival recession REC

    using periodontal probe in mm

    6 months

Study Arms (2)

L-PRF

ACTIVE COMPARATOR

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

Procedure: L-PRF

L-PRF with aPDT

ACTIVE COMPARATOR

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

Procedure: L-PRF with aPDT

Interventions

L-PRF with aPDTPROCEDURE

surgical open flap debridement followed by L-PRF with aPDT

L-PRF with aPDT
L-PRFPROCEDURE

surgical open flap debridement followed by L-PRF alone

L-PRF

Eligibility Criteria

Age32 Years - 48 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, 214312, Egypt

Location

MeSH Terms

Conditions

Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral medicine and periodontology

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 13, 2021

Study Start

July 28, 2020

Primary Completion

April 12, 2021

Study Completion

April 30, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)