- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04842188
Furcation Treatment With L-PRF and aPDT
Evaluation of Leukocyte Platelet Rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Furcation Involvement: Randomised Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kafr Ash Shaykh, Egypt, 214312
- faculty of dentistry, kafrelsheikh University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: L-PRF
Leukocyte platelet rich fibrin as a sole graft material in class II furcation
|
surgical open flap debridement followed by L-PRF alone
|
ACTIVE_COMPARATOR: L-PRF with aPDT
Leukocyte platelet rich fibrin combined with antibacterial photodynamic therapy in class II furcation
|
surgical open flap debridement followed by L-PRF with aPDT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical evaluation of Vertical clinical attachment level VCAL
Time Frame: 6 months
|
using periodontal probe in mm
|
6 months
|
clinical evaluation of vertical pocket depth VPD
Time Frame: 6 months
|
using periodontal probe in mm
|
6 months
|
clinical evaluation of furcation horizontal component FHC
Time Frame: 6 months
|
using periodontal probe in mm
|
6 months
|
clinical evaluation of gingival recession REC
Time Frame: 6 months
|
using periodontal probe in mm
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- elamrousy2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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