L-PRFNCT05043935
The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis
A study testing L-PRF with antimicrobial photodynamic therapy and antimicrobial photodynamic therapy without L-PRF in people with L-PRF and Photodynamic Therapy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Antimicrobial photodynamic therapy (aPDT) is associated with photosensitizing agents which promote the generation of free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- L-PRF, Photodynamic Therapy, Aggressive Periodontitis
- What is being tested?
- L-PRF with antimicrobial photodynamic therapy and antimicrobial photodynamic therapy without L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2021to Oct 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemically healthy
- non- smoker,
- not received any periodontal treatment within the last 6 months,
- no antibiotics, anti- inflammatory drugs or any other medication taken within the last 6 months
Who cannot join
- any systemic disease that might influence the prognosis of periodontal disease and outcome of the treatment,
- any medical condition that required antibiotic prophylaxis before the treatment,
- smoking,
- pregnancy and lactation,
- ingestion of antibiotics, anti-inflammatory drugs or any other medication during the study period,
- any physical limitations or restrictions that might preclude normal oral hygiene procedures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, 33511
Dalia R Issa, PhD, 01007753636 ext. 002, dalia_rasheed@hotmail.com
About this study
Official title: The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis Patients: A Randomized Controlled Clinical Trial
Antimicrobial photodynamic therapy (aPDT) is associated with photosensitizing agents which promote the generation of free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Leukocyte and platelet-rich fibrin (L-PRF) has been used extensively in the treatment of intrabony defects and achieved excellent results. It acts as an immune regulation node with inflammation control abilities, including a slow continuous release of growth factors which stimulates periodontal regeneration. The aim of this study is to evaluate the adjunctive effects of aPDT with and without L-PRF in aggressive periodontitis patients.
- Conditions
- L-PRF, Photodynamic Therapy, Aggressive Periodontitis
- Being tested
- L-PRF with antimicrobial photodynamic therapy, antimicrobial photodynamic therapy without L-PRF
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRF with antimicrobial photodynamic therapyProcedure or surgery
Application of L-PRF with antimicrobial photodynamic therapy in the defect
antimicrobial photodynamic therapy without L-PRFProcedure or surgery
application of antimicrobial photodynamic therapy without L-PRF in the defect
| Study group | Role | What they receive |
|---|---|---|
| L-PRF with antimicrobial photodynamic therapy | Experimental | Application of L-PRF with antimicrobial photodynamic therapy in the defect Receives: Procedure: L-PRF with antimicrobial photodynamic therapy |
| antimicrobial photodynamic therapy | Active comparator | Application antimicrobial photodynamic therapy in the defect Receives: Procedure: antimicrobial photodynamic therapy without L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation and measurements of the defect in millimeters
Changes in clinical measurements in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF
Measured: 9 months
Radiographic evaluation and measurements of the defect in millimeters
Changes in bone formation in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start22 Nov 2021
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for L-PRFStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Rasheed Issa, Kafrelsheikh University
- Investigators
- Dalia R Issa, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043935
- Sponsor's protocol ID
- waiting
- Status last verified
- Apr 2024
- First submitted
- 20 Aug 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05043935
- Acronym / sponsor ID
- waiting
- Conditions
- L-PRF, Photodynamic Therapy, Aggressive Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 14 Sep 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.
Antimicrobial photodynamic therapy (aPDT) is associated with photosensitizing agents which promote the generation of free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Leukocyte and platelet-rich fibrin (L-PRF) has been used extensively in the treatment of intrabony defects and achieved excellent results. It acts as an immune regulation node with inflammation control abilities, including a slow continuous release of growth factors which stimulates periodontal regeneration. The aim of this study is to evaluate the adjunctive effects of aPDT with and without L-PRF in aggressive periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-PRF with antimicrobial photodynamic therapy | Experimental | Procedure: L-PRF with antimicrobial photodynamic therapyApplication of L-PRF with antimicrobial photodynamic therapy in the defect |
| antimicrobial photodynamic therapy | Active comparator | Procedure: antimicrobial photodynamic therapy without L-PRFApplication antimicrobial photodynamic therapy in the defect |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- systemically healthy
- non- smoker,
- not received any periodontal treatment within the last 6 months,
- no antibiotics, anti- inflammatory drugs or any other medication taken within the last 6 months
Key exclusion criteria (6 listed)
- any systemic disease that might influence the prognosis of periodontal disease and outcome of the treatment,
- any medical condition that required antibiotic prophylaxis before the treatment,
- smoking,
- pregnancy and lactation,
- ingestion of antibiotics, anti-inflammatory drugs or any other medication during the study period,
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 antimicrobial photodynamic therapyApplication of L-PRF with antimicrobial photodynamic therapy in the defect | Procedure or surgery | L-PRF with antimicrobial photodynamic therapy |
| antimicrobial photodynamic therapy without L-PRFapplication of antimicrobial photodynamic therapy without L-PRF in the defect | Procedure or surgery | antimicrobial photodynamic therapy |
Primary outcome
Clinical evaluation and measurements of the defect in millimeters
Time frame: 9 months
Changes in clinical measurements in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF
Radiographic evaluation and measurements of the defect in millimeters
Time frame: 9 months
Changes in bone formation in millimeters after application of antimicrobial photodynamic therapy with and without L-PRF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
Dalia R Issa, PhD principal investigator
Kafrelsheikh University
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 antimicrobial photodynamic therapy and antimicrobial photodynamic therapy without L-PRF in people with L-PRF and Photodynamic Therapy, 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 4 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia R Issa, PhD (01007753636 ext. 002, dalia_rasheed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation and measurements of the defect in millimeters (time frame: 9 months). The study lists 2 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 11 Apr 2024.