Intrabony Periodontal DefectNCT06297577
Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients
A study testing Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) and Minimally invasive surgical technique (MIST) in people with Intrabony Periodontal Defect, run by Cairo University.
Trial summary
Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) and Minimally invasive surgical technique (MIST)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2024to 30 Oct 2025
- 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
- Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area.
- Vital teeth.
- No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- No periodontal therapy carried out in the past 6 months.
- Ability to sign an informed consent form.
- Patients age ≥18 years old.
- Patients who are cooperative, motivated, and hygiene conscious.
- Systemically free according to Cornell Medical Index.
Who cannot join
- Patient undergoing orthodontic treatment.
- Pregnant females or breast feeding.
- Smokers.
- Teeth mobility greater than grade I.
Trial locations and contacts
No sites are listed yet.
Manal Hosny, Professor contact
About this study
Official title: Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin (Alb-PRF) Versus Minimally Invasive Surgical Technique (MIST) in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. A Randomized Controlled Clinical Trial
Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.
The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:
will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST), Minimally invasive surgical technique (MIST)
- Keywords
- Albumin Platelet Rich Fibrin (Alb-PRF), Minimally Invasive Surgical Technique (MIST), Stage 3 periodontitis, Intrabony defect
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)Procedure or surgery
Albumin-PRF will be placed into intrabony defect
Minimally invasive surgical technique (MIST)Procedure or surgery
MIST will be the surgical access for treatment of Intrabony defect
| Study group | Role | What they receive |
|---|---|---|
| Albumin Platelet Rich Fibrin (Alb-PRF) | Experimental | For the production of Alb-PRF membrane, two 10 ml vacuum plastic tubes will be centrifuged at 700 g for 8 minutes. After centrifugation, the upper layer (yellow layer) shows the liquid plasma layer. The most upper layer of platelet-poor plasma (PPP) will be collected in a syringe and then will be heated in a heat block device at 75°C for 10 minutes to create denatured albumin (albumin gel). After heating, the albumin gel will be cooled to room temperature for approximately 10 minutes. An injectable albumin gel was then prepared. The liquid platelet-rich layer (liquid-PRF), including the buffy coat layer with accumulated platelets, leukocytes and growth factors, will be collected in a separate syringe and will be reserved at room temperature (20°C). The albumin gel and liquid PRF will be then thoroughly mixed by utilizing a female-female luer lock connector Receives: Procedure: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) |
| Minimally Invasive Surgical Technique (MIST) | Active comparator | Surgical approach will be the Minimally Invasive Surgical Technique (MIST) approach according to; simplified or modified papilla-preservation flap design upon the papilla width.
Defects will be thoroughly debrided using Gracey curettes and ultrasonic scalers.
Then, a single internal mattress suture using 5-0 polypropylene sutures will be placed at the defect-associated inter-dental area. Receives: Procedure: Minimally invasive surgical technique (MIST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.
Measured: CAL will be measured at base line, 6, and 9 months postoperative
Secondary outcomes (5)
Probing Depth (PD)
PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.
Measured: CAL will be measured at base line, 6, and 9 months postoperative
Radiographic Linear Defect Depth (RLDD)
Individually customized bite blocks will be fabricated for each patient and parallel-angle technique will be employed using X-ray film holding system. Periapical radiograph PSP sensor size two and standardized exposure setting of 60 kVp, 8 mA, 0.7 mm, and 0.10 s will be used. RLDD will be measured as the depth of the intrabony defect from the alveolar crest (AC) to the defect base (DB)
Measured: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
Recession Depth (RD)
RD will be measured from the cemento-enamel junction to the most apical extension of the gingival margin using the University of North Carolina periodontal probe at six sites per tooth.
Measured: RD will be measured at base line, 6, and 9 months postoperative
Post-operative Pain
The visual analogue scale (VAS) score (0-10)
Measured: During first week postoperative
Radiographic defect fill (RDF)
Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values
Measured: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start30 Aug 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mashaal Mohammed Abdullah Mohammed, Cairo University
- Investigators
- Manal Hosny, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297577
- Sponsor's protocol ID
- MASH2024
- Status last verified
- Aug 2024
- First submitted
- 18 Feb 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: starting 6 months after publication
Publications
Fujioka-Kobayashi M, Schaller B, Mourao CFAB, Zhang Y, Sculean A, Miron RJ. Biological characterization of an injectable platelet-rich fibrin mixture consisting of autologous albumin gel and liquid platelet-rich fibrin (Alb-PRF). Platelets. 2021 Jan 2;32(1):74-81. doi: 10.1080/09537104.2020.1717455. Epub 2020 Jan 20.
PubMed 31959025Miron RJ, Chai J, Fujioka-Kobayashi M, Sculean A, Zhang Y. Evaluation of 24 protocols for the production of platelet-rich fibrin. BMC Oral Health. 2020 Nov 7;20(1):310. doi: 10.1186/s12903-020-01299-w.
PubMed 33160335Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.
PubMed 29926951Pavlovic V, Ciric M, Jovanovic V, Trandafilovic M, Stojanovic P. Platelet-rich fibrin: Basics of biological actions and protocol modifications. Open Med (Wars). 2021 Mar 22;16(1):446-454. doi: 10.1515/med-2021-0259. eCollection 2021.
PubMed 33778163Alshoiby MM, Fawzy El-Sayed KM, Elbattawy W, Hosny MM. Injectable platelet-rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jul;27(7):3457-3467. doi: 10.1007/s00784-023-04954-y. Epub 2023 Mar 31.
PubMed 37002441Gheno E, Mourao CFAB, Mello-Machado RC, Stellet Lourenco E, Miron RJ, Catarino KFF, Alves AT, Alves GG, Calasans-Maia MD. In vivo evaluation of the biocompatibility and biodegradation of a new denatured plasma membrane combined with liquid PRF (Alb-PRF). Platelets. 2021 May 19;32(4):542-554. doi: 10.1080/09537104.2020.1775188. Epub 2020 Jun 12.
PubMed 32531175
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin (Alb-PRF) Versus Minimally Invasive Surgical Technique (MIST) in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06297577
- Acronym / sponsor ID
- MASH2024
- Conditions
- Intrabony Periodontal Defect
- Keywords
- Albumin Platelet Rich Fibrin (Alb-PRF), Minimally Invasive Surgical Technique (MIST), Stage 3 periodontitis, Intrabony defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 7 Mar 2024 (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.
Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.
The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:
will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin Platelet Rich Fibrin (Alb-PRF) | Experimental | Procedure: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)For the production of Alb-PRF membrane, two 10 ml vacuum plastic tubes will be centrifuged at 700 g for 8 minutes. After centrifugation, the upper layer (yellow layer) shows the liquid plasma layer. The most upper layer of platelet-poor plasma (PPP) will be collected in a syringe and then will be heated in a heat block device at 75°C for 10 minutes to create denatured albumin (albumin gel). After heating, the albumin gel will be cooled to room temperature for approximately 10 minutes. An injectable albumin gel was then prepared. The liquid platelet-rich layer (liquid-PRF), including the buffy coat layer with accumulated platelets, leukocytes and growth factors, will be collected in a separate syringe and will be reserved at room temperature (20°C). The albumin gel and liquid PRF will be then thoroughly mixed by utilizing a female-female luer lock connector |
| Minimally Invasive Surgical Technique (MIST) | Active comparator | Procedure: Minimally invasive surgical technique (MIST)Surgical approach will be the Minimally Invasive Surgical Technique (MIST) approach according to; simplified or modified papilla-preservation flap design upon the papilla width. Defects will be thoroughly debrided using Gracey curettes and ultrasonic scalers. Then, a single internal mattress suture using 5-0 polypropylene sutures will be placed at the defect-associated inter-dental area. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area.
- Vital teeth.
- No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- No periodontal therapy carried out in the past 6 months.
- Ability to sign an informed consent form.
Key exclusion criteria (4 listed)
- Patient undergoing orthodontic treatment.
- Pregnant females or breast feeding.
- Smokers.
- Teeth mobility greater than grade I.
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 |
|---|---|---|
| Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)Albumin-PRF will be placed into intrabony defect | Procedure or surgery | Albumin Platelet Rich Fibrin (Alb-PRF) |
| Minimally invasive surgical technique (MIST)MIST will be the surgical access for treatment of Intrabony defect | Procedure or surgery | Minimally Invasive Surgical Technique (MIST) |
Primary outcome
Clinical attachment level (CAL)
Time frame: CAL will be measured at base line, 6, and 9 months postoperative
CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.
5 secondary outcomes
Probing Depth (PD)
Time frame: CAL will be measured at base line, 6, and 9 months postoperative
Radiographic Linear Defect Depth (RLDD)
Time frame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
Recession Depth (RD)
Time frame: RD will be measured at base line, 6, and 9 months postoperative
Post-operative Pain
Time frame: During first week postoperative
Radiographic defect fill (RDF)
Time frame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Results publication: PubMed 31959025Fujioka-Kobayashi M, Schaller B, Mourao CFAB, Zhang Y, Sculean A, Miron RJ. Biological characterization of an injectable platelet-rich fibrin mixture consisting of autologous albumin gel and liquid platelet-rich fibrin (Alb-PRF). Platelets. 2021 Jan 2;32(1):74-81. doi: 10.1080/09537104.2020.1717455. Epub 2020 Jan 20.
- Results publication: PubMed 33160335Miron RJ, Chai J, Fujioka-Kobayashi M, Sculean A, Zhang Y. Evaluation of 24 protocols for the production of platelet-rich fibrin. BMC Oral Health. 2020 Nov 7;20(1):310. doi: 10.1186/s12903-020-01299-w.
- Results publication: PubMed 29926951Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.
- Results publication: PubMed 33778163Pavlovic V, Ciric M, Jovanovic V, Trandafilovic M, Stojanovic P. Platelet-rich fibrin: Basics of biological actions and protocol modifications. Open Med (Wars). 2021 Mar 22;16(1):446-454. doi: 10.1515/med-2021-0259. eCollection 2021.
- Results publication: PubMed 37002441Alshoiby MM, Fawzy El-Sayed KM, Elbattawy W, Hosny MM. Injectable platelet-rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jul;27(7):3457-3467. doi: 10.1007/s00784-023-04954-y. Epub 2023 Mar 31.
- Results publication: PubMed 32531175Gheno E, Mourao CFAB, Mello-Machado RC, Stellet Lourenco E, Miron RJ, Catarino KFF, Alves AT, Alves GG, Calasans-Maia MD. In vivo evaluation of the biocompatibility and biodegradation of a new denatured plasma membrane combined with liquid PRF (Alb-PRF). Platelets. 2021 May 19;32(4):542-554. doi: 10.1080/09537104.2020.1775188. Epub 2020 Jun 12.
- Individual participant dataSharing planned: No. starting 6 months after publication
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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.
Manal Hosny, Professor contact
Manal Hosny, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) and Minimally invasive surgical technique (MIST) in people with Intrabony Periodontal Defect, run by Cairo University.
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 4 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Mashaal Mohammed, Master (00201094483995, mashaal.abdullah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level (CAL) (time frame: CAL will be measured at base line, 6, and 9 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297577, which also lists 6 linked publications.
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 7 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.