Periodontal DiseasesNCT04576468
The Use of Leucocyte Platelet Rich Fibrin (L- PRF) Covered Perforated Guided Tissue Membrane for Treatment of Periodontal Intrabony Defects
A study testing Open flap debridement, perforated membrane and leucocyte - platelet rich fibrin in people with Periodontal Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is the first to investigate the effect of leucocyte platelet rich fibrin (L-PRF) combined with perforated membrane in order to treat infrabony defects and assess their combined effect in clinical attachment level gain and filling of base of the defect (BD). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Open flap debridement, perforated membrane and leucocyte - platelet rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 31 Dec 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders aged from 18- 60 years.
- Patients free from any systemic diseases that may contra-indicate periodontal surgery (Ahmed Y. Gamal et al., 2014).
- Two- or three-wall intrabony defects in premolar/molar teeth without furcation involvement, that are measured from the alveolar crest to the defect bottom in diagnostic periapical radiographs of ≥ 3 mm (Reynolds et al., 2015).
- Probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm at the site of intrabony defects 4 week after the phase one therapy (Ahmed Y. Gamal et al., 2014).
- Free from any periapical pathosis.
- Patients willing and able to return for multiple follow up visits and perform oral hygiene instructions.
- Absence of occlusal interference, mobility and open interproximal contact.
- Good fulfillment to plaque control instructions following initial therapy.
Who cannot join
- Smokers.
- Pregnant and breast feeding females.
- Periodontal surgical treatment in the previous 12 months at the involved sites. (A. Y. Gamal et al., 2016)
- Persistence of gingival inflammation after phase I therapy.
- Vulnerable groups as handicapped, mentally disabled, prisoners and orphans.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Leucocyte Platelet Rich Fibrin (L- PRF) Covered Perforated Guided Tissue Membrane for Treatment of Periodontal Intrabony Defects (Randomized Clinical Trial)
This study is the first to investigate the effect of leucocyte platelet rich fibrin (L-PRF) combined with perforated membrane in order to treat infrabony defects and assess their combined effect in clinical attachment level gain and filling of base of the defect (BD). The main hypothesis was that if the L-PRF act as a chemoattracttant for a higher number of periosteal derived periodontal cells (PDPCs) and gingival mesenchymal stem cells (GMSCs) encouraging their passage through the membrane perforations.
Read the detailed description
A randomized (controlled) clinical trial which included forty sites with intrabony interproximal defects (2- or 3-wall) premolar/molar teeth assessed for clinical parameters. The four treatment modalities were randomly allocated by a predetermined computer generated randomization list (www.randomizer.org) into four equal groups; Group I (control group) open flap debridement (OFD): included intrabony defects treated by open flap debridement (OFD).Group II perforated membrane (PM): included intrabony defects treated by perforated membranes.Group III Leucocyte-platelet rich fibrin (L-PRF): included intrabony defects treated by leukocytes platelet rich fibrin (L-PRF). Group IV Leucocyte-platelet rich fibrin + perforated membrane (L-PRF + PM): included intrabony defects treated by Leucocyte platelet rich fibrin \& perforated membranes.
- Conditions
- Periodontal Diseases
- Being tested
- Open flap debridement, perforated membrane, leucocyte - platelet rich fibrin
- Keywords
- perforated membrane, L-PRF, guided tissue regeneration, vertical defects, Intrabony defects
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open flap debridementProcedure or surgery
Also called OFD
Surgical intevention
perforated membraneProcedure or surgery
Also called perforated guided tissue membrane, regenerative surgery
surgical intervention
leucocyte - platelet rich fibrinProcedure or surgery
Also called L-PRF, regenerative surgery
surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| open flap debridement | Experimental | envelope full thickness flap reflection, removal of granulation tissue then suturing with simple loop sutures. Receives: Procedure: Open flap debridement |
| perforated membrane (PM) | Experimental | envelope full thickness flap reflection, removal of granulation tissue placing resorbable membrane after perforating it over the vertical defect then suturing with simple loop sutures. Receives: Procedure: Open flap debridement; Procedure: perforated membrane |
| leucocyte platelet rich fibrin (L-PRF) | Experimental | envelope full thickness flap reflection, removal of granulation tissue after withdrawal of blood and placing it in intraspin centrifuge , placing the resulting L-PRF in the defect then suturing with simple loop sutures. Receives: Procedure: Open flap debridement; Procedure: leucocyte - platelet rich fibrin |
| L-PRF + PM | Experimental | envelope full thickness flap reflection, removal of granulation tissue after withdrawal of blood and placing it in intraspin centrifuge , placing the resulting L-PRF covered by resorbable membrane after perforating it in the defect then suturing with simple loop sutures. Receives: Procedure: Open flap debridement; Procedure: perforated membrane; Procedure: leucocyte - platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachement level gain
measured using University of North Carolina Periodontal probe change from baseline at 6 month
Measured: 6 month
Secondary outcomes (1)
radiographic bone fill
measured using standardized periapical radiograph change from baseline at 6 month
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- patients equally distributed into 4 groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Future University in Egypt
- Responsible party
- Principal investigator, Mariam Samir, Ain Shams University
- Investigators
- Ahmed Y Gamal, Professor, Study director, Faculty of dentistry - Ain shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576468
- Sponsor's protocol ID
- FDAS-RecIM011735
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Leucocyte Platelet Rich Fibrin (L- PRF) Covered Perforated Guided Tissue Membrane for Treatment of Periodontal Intrabony Defects (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04576468
- Acronym / sponsor ID
- FDAS-RecIM011735
- Conditions
- Periodontal Diseases
- Keywords
- perforated membrane, L-PRF, guided tissue regeneration, vertical defects, Intrabony defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Future University in Egypt
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Oct 2020 (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.
This study is the first to investigate the effect of leucocyte platelet rich fibrin (L-PRF) combined with perforated membrane in order to treat infrabony defects and assess their combined effect in clinical attachment level gain and filling of base of the defect (BD). The main hypothesis was that if the L-PRF act as a chemoattracttant for a higher number of periosteal derived periodontal cells (PDPCs) and gingival mesenchymal stem cells (GMSCs) encouraging their passage through the membrane perforations.
Detailed description
A randomized (controlled) clinical trial which included forty sites with intrabony interproximal defects (2- or 3-wall) premolar/molar teeth assessed for clinical parameters. The four treatment modalities were randomly allocated by a predetermined computer generated randomization list (www.randomizer.org) into four equal groups; Group I (control group) open flap debridement (OFD): included intrabony defects treated by open flap debridement (OFD).Group II perforated membrane (PM): included intrabony defects treated by perforated membranes.Group III Leucocyte-platelet rich fibrin (L-PRF): included intrabony defects treated by leukocytes platelet rich fibrin (L-PRF). Group IV Leucocyte-platelet rich fibrin + perforated membrane (L-PRF + PM): included intrabony defects treated by Leucocyte platelet rich fibrin \& perforated membranes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- patients equally distributed into 4 groups
| Arm | Type | Receives |
|---|---|---|
| open flap debridement | Experimental | Procedure: Open flap debridementenvelope full thickness flap reflection, removal of granulation tissue then suturing with simple loop sutures. |
| perforated membrane (PM) | Experimental | Procedure: Open flap debridement, Procedure: perforated membraneenvelope full thickness flap reflection, removal of granulation tissue placing resorbable membrane after perforating it over the vertical defect then suturing with simple loop sutures. |
| leucocyte platelet rich fibrin (L-PRF) | Experimental | Procedure: Open flap debridement, Procedure: leucocyte - platelet rich fibrinenvelope full thickness flap reflection, removal of granulation tissue after withdrawal of blood and placing it in intraspin centrifuge , placing the resulting L-PRF in the defect then suturing with simple loop sutures. |
| L-PRF + PM | Experimental | Procedure: Open flap debridement, Procedure: perforated membrane, Procedure: leucocyte - platelet rich fibrinenvelope full thickness flap reflection, removal of granulation tissue after withdrawal of blood and placing it in intraspin centrifuge , placing the resulting L-PRF covered by resorbable membrane after perforating it in the defect then suturing with simple loop sutures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Both genders aged from 18- 60 years.
- Patients free from any systemic diseases that may contra-indicate periodontal surgery (Ahmed Y. Gamal et al., 2014).
- Two- or three-wall intrabony defects in premolar/molar teeth without furcation involvement, that are measured from the alveolar crest to the defect bottom in diagnostic periapical radiographs of ≥ 3 mm (Reynolds et al., 2015).
- Probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm at the site of intrabony defects 4 week after the phase one therapy (Ahmed Y. Gamal et al., 2014).
- Free from any periapical pathosis.
Key exclusion criteria (5 listed)
- Smokers.
- Pregnant and breast feeding females.
- Periodontal surgical treatment in the previous 12 months at the involved sites. (A. Y. Gamal et al., 2016)
- Persistence of gingival inflammation after phase I therapy.
- Vulnerable groups as handicapped, mentally disabled, prisoners and orphans.
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 |
|---|---|---|
| Open flap debridementAlso: OFDSurgical intevention | Procedure or surgery | L-PRF + PM, leucocyte platelet rich fibrin (L-PRF), open flap debridement, perforated membrane (PM) |
| perforated membraneAlso: perforated guided tissue membrane, regenerative surgerysurgical intervention | Procedure or surgery | L-PRF + PM, perforated membrane (PM) |
| leucocyte - platelet rich fibrinAlso: L-PRF, regenerative surgerysurgical intervention | Procedure or surgery | L-PRF + PM, leucocyte platelet rich fibrin (L-PRF) |
Primary outcome
clinical attachement level gain
Time frame: 6 month
measured using University of North Carolina Periodontal probe change from baseline at 6 month
1 secondary outcome
radiographic bone fill
Time frame: 6 month
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 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Ahmed Y Gamal, Professor study director
Faculty of dentistry - Ain shams 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 Open flap debridement, perforated membrane and leucocyte - platelet rich fibrin in people with Periodontal Diseases, run by Ain Shams 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 8 inclusion and 5 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 8 Oct 2020. 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 attachement level gain (time frame: 6 month). 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 8 Oct 2020.