Furcation DefectsNCT04842188
Furcation Treatment With L-PRF and aPDT
A study testing L-PRF with aPDT and L-PRF in people with Furcation Defects, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects
- What is being tested?
- L-PRF with aPDT and L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Grade II furcation involvement
- age range 18- 50 years
- 3 mm or more vertical probing depth
Who cannot join
- systemic disease
- abnormal clotting and bleeding
- smokers,
- root caries or restoration
- Grade II mobility
- periapical lesions
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, 214312
About this study
Official title: Evaluation of Leukocyte Platelet Rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Furcation Involvement: Randomised Clinical Study
To treat grade II periodontally diseased furcation areas Leukocyte-Platelet Rich Fibrin (L-PRF) combined with antimicrobial Photo-Dynamic Therapy (a-PDT) was used.
Read the 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
- Conditions
- Furcation Defects
- Being tested
- L-PRF with aPDT, L-PRF
- Keywords
- platelet rich fibrin, photodynamic therapy
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRF with aPDTProcedure or surgery
surgical open flap debridement followed by L-PRF with aPDT
L-PRFProcedure or surgery
surgical open flap debridement followed by L-PRF alone
| Study group | Role | What they receive |
|---|---|---|
| L-PRF | Active comparator | Leukocyte platelet rich fibrin as a sole graft material in class II furcation Receives: Procedure: L-PRF |
| L-PRF with aPDT | Active comparator | Leukocyte platelet rich fibrin combined with antibacterial photodynamic therapy in class II furcation Receives: Procedure: L-PRF with aPDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of Vertical clinical attachment level VCAL
using periodontal probe in mm
Measured: 6 months
clinical evaluation of vertical pocket depth VPD
using periodontal probe in mm
Measured: 6 months
clinical evaluation of furcation horizontal component FHC
using periodontal probe in mm
Measured: 6 months
clinical evaluation of gingival recession REC
using periodontal probe in mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start28 Jul 2020
- Primary completion12 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842188
- Sponsor's protocol ID
- elamrousy2020
- Status last verified
- Jun 2021
- First submitted
- 8 Apr 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Leukocyte Platelet Rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Furcation Involvement: Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT04842188
- Acronym / sponsor ID
- elamrousy2020
- Conditions
- Furcation Defects
- Keywords
- platelet rich fibrin, photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-PRF | Active comparator | Procedure: L-PRFLeukocyte platelet rich fibrin as a sole graft material in class II furcation |
| L-PRF with aPDT | Active comparator | Procedure: L-PRF with aPDTLeukocyte platelet rich fibrin combined with antibacterial photodynamic therapy in class II furcation |
Who may qualify
- Ages
- 32 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Grade II furcation involvement
- age range 18- 50 years
- 3 mm or more vertical probing depth
Key exclusion criteria (6 listed)
- systemic disease
- abnormal clotting and bleeding
- smokers,
- root caries or restoration
- Grade II mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-PRF with aPDTsurgical open flap debridement followed by L-PRF with aPDT | Procedure or surgery | L-PRF with aPDT |
| L-PRFsurgical open flap debridement followed by L-PRF alone | Procedure or surgery | L-PRF |
Primary outcome
Clinical evaluation of Vertical clinical attachment level VCAL
Time frame: 6 months
using periodontal probe in mm
clinical evaluation of vertical pocket depth VPD
Time frame: 6 months
using periodontal probe in mm
clinical evaluation of furcation horizontal component FHC
Time frame: 6 months
using periodontal probe in mm
clinical evaluation of gingival recession REC
Time frame: 6 months
using periodontal probe in mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Furcation Defects
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Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
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Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-PRF with aPDT and L-PRF in people with Furcation Defects, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of Vertical clinical attachment level VCAL (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.