Periodontal Bone LossALB-PRFNCT06798116
Treatment of Periodontal Intrabony Defects With Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB_PRF)
A study testing Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF, defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects and defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane in people with Periodontal Bone Loss and Periodontitis Stage III, run by Mansoura University at 1 site in Egypt.
Trial summary
The objective of study also is to assess radiographic linear defect depth, and radiographic defect bone density following the application of liquid Platelet-Rich Fibrin (PRF) mixed with denaturated Albumin gel (ALB-PRF) or with bone allograft in periodontal intrabony defects. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Periodontal Bone Loss, Periodontitis Stage III, Intra-bony Pockets
- What is being tested?
- Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF, defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects and defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2024to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Periodontist stage III according to classification of periodontal and peri-implant disease and conditions (2018).
- Patient with two or three walls or combined bony defect.
- Favourable pattern of occlusion.
- Patient ability to comply with the required recall visits.
Who cannot join
- Local or systemic diseases that contraindicate surgery.
- Smokers
- Patients with parafunctional habits.
- Pregnancy or lactation.
- Diabetic patient.
- Osteoporosis.
- Immune-suppressed condition that may affect the outcome of the therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB-PRF) or With Bone Allograft in The Treatment of Periodontal Intrabony Defects( Randomized Controlled Clinical Trial)
The objective of study also is to assess radiographic linear defect depth, and radiographic defect bone density following the application of liquid Platelet-Rich Fibrin (PRF) mixed with denaturated Albumin gel (ALB-PRF) or with bone allograft in periodontal intrabony defects.
Patients and methods: 28 patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University according to Pre-operative CBCT that will be used to evaluate the bone destruction pattern. According to the techniques that used in the treatment of periodontal bony defect, the participants will be randomly divided into 4 equal groups: Group I: will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF). Group II: will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. Group III: will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. Group IV: will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
Read the detailed description
28 patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University according to Pre-operative CBCT that will be used to evaluate the bone destruction pattern.
Sample size will be calculated using G-Power 3.1 for Mac with (α = 0.05, and power = 0.95). One-way ANOVA test will be used and effect size of (0.7) based on the anticipated mean difference of the efficacy of new generation platelet-rich fibrin according Nagy et.al 2021. The total sample size of the four groups will be 28 patients.
Inclusion criteria:
- periodontits stage III according to classification of periodontal and peri-implant disease and conditions (2018).
- Patient with two or three walls or combined bony defect.
- Favorable pattern of occlusion.
- Patient ability to comply with the required recall visits.
Exclusion Criteria:
- Local or systemic diseases that contraindicate surgery.
- Smokers
- Patients with parafunctional habits.
- Pregnancy or lactation.
- Diabetic patient.
- Osteoporosis.
- Immune-suppressed condition that may affect the outcome of the therapy.
- Study design:
According to the techniques that used in the treatment of periodontal bony defect, the participants will be randomly divided into 4 equal groups:
Group I: will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF).
Group II: will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects.
Group III: will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane.
Group IV: will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
II) Surgical Procedures ,liquid PRF and ALB-PRF preparation:
Patients will be premedicated by Amoxicillin 2 gm one hour before surgery as a prophylactic antibiotic, in addition patient will instructed to rinse with a 0.2% chlorhexidine mouth wash for 1 minute immediately prior to surgery.
All patients will be subjected to surgical procedure consisting of the injection of local anaesthetic Articaine hydrochloride 4% with epinephrine (1:100,000) followed by sulcular incision with 15c blade, reflection of a full thickness flap atraumaticlly , open flap debridement using periodontal curettes to remove all tissue tags and granulation tissue. Ethylenediaminetetraacetic acid (EDTA) will be applied to the root surface followed by rinsing with normal saline.
Liquid (PRF) and ALB-PRF Preparation:
As the protocol entails drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min.
The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form.
In group I, the defects will be treated with open flap debridement and DFDBA and mixed with liquid (PRF). In group II, the defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. In group III, the defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane. In group IV, the defects will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane. Vertical mattress suture with 5-0 suture will be used to close the wound.
Patients will be instructed to use 0.2% chlorhexidine gluconate mouth wash for 1 minute twice a day for 2 weeks, also maintained on amoxicillin 1gm twice a day for six days postoperatively and Ibuprofen 400 mg will be prescribed to be taken 2 to 4 times a day during meals as analgesic.
Clinical assessment: Pain and bruising will be obtain using Visual Analogue Scales (VAS) on days 0, 3, 5 and 7 post-operatively. While healing will be assess at days 2,7 and 14. The following periodontal indices will be assessed at baseline, 3 and 6 months: Plaque index (PI). Bleeding on Probing (BOP). Pocket depth (PD). Clinical Attachment Level (CAL). Radiographic Assessment: Using cone beam CT (CBCT) scan to assess linear bone defect depth and defect bone density at baseline and 6 months.
Statistical analysis: The data will be collected and statistical analysis will be done using SPSS(statistical package for social sciences) version 2024.
- Being tested
- Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF, defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects, defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane, open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
- Keywords
- ALB-PRF, intrabony defect, periodontitis
- Medical subject headings
- Alveolar Bone Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRFProcedure or surgery
Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min.
The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement and DFDBA and mixed with liquid (PRF)
defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defectsProcedure or surgery
Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min.
The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects.
defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membraneProcedure or surgery
Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min.
The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane
open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane.Procedure or surgery
Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min.
The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
| Study group | Role | What they receive |
|---|---|---|
| open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF) | Experimental | will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF). Receives: Procedure: Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF |
| liquid (PRF) mixed with denatured albumin gel (ALB-PRF) injected in periodontal intrabony defects | Experimental | will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. Receives: Procedure: defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects |
| open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. | Active comparator | will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. Receives: Procedure: defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane |
| open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane. | Experimental | will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane. Receives: Procedure: open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pocket depth
pocket depth: by placing dental probe between your teeth and gumline. Pockets are measured at several places in your upper and lower gums. In a healthy mouth, the pocket depth is usually between 1 and 3 millimetres (mm). Pockets deeper than 4 mm may indicate periodontitis
Measured: pocket depth will be assessed at baseline, 3 and 6 months.
Plaque index
Evaluation of existence plaque in all around tooth aspects
Measured: At baseline ,3and 6 months
Bleeding on Probing
Evaluation of existence Bleeding during gentle periodontal probing.
Measured: At baseline ,3 and 6months.
Clinical Attachment Level
To assess the clinical attachment level.
Measured: At baseline ,3 and 6 months.
Secondary outcomes (4)
Pain score
The patients will report their pain score directly through VAS score (between 0 and 10; 0: no pain, 1: minimal pain, 5: moderate pain, and 10: severe pain).
Measured: At day 0,3,5 and 7 post-operatively. While healing will be assess at days 2,7 and 14
Alveolar ridge width (buccolingual).
Will be assessed via Cone-Beam Computed Tomography (CBCT) that Provides a radiographic assessment of the buccolingual width by measuring the distance between buccal and lingual bone walls.
Measured: At base line and 6 months starting from base line.
Alveolar ridge height (apicocronal)
Will be assessed via Cone-Beam Computed Tomography (CBCT) that Provides a radiographic assessment of the apicocronal height by measuring the ridge height from the top of the alveolar ridge to the upper border of the alveolar canal.
Measured: At base line and 6 months starting from base line.
Bone density
Will be assessed via Cone-Beam Computed Tomography (CBCT) The measurement helps in assessing the quality of bone directly through Hounsfield units (HU) (between D1 and D5; D1: > 1250 HU, D2: 850 to 1250 HU, D3: 350 to 850 HU, D4: 150 to 350 HU, D5: < 150 HU).
Measured: At base line and 6 months starting from base line.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start3 Jan 2024
- Primary completion24 Jan 2025 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Bone LossStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- surgery and give medication
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhaidan Naif Alshammari, Bachelor, Principal investigator, faculty of dentistry Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798116
- Sponsor's protocol ID
- A04011023OM
- Acronym
- ALB-PRF
- Status last verified
- Jan 2025
- First submitted
- 5 Nov 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after Completing the study ; the data will be available when requested
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB-PRF) or With Bone Allograft in The Treatment of Periodontal Intrabony Defects( Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06798116
- Acronym / sponsor ID
- ALB-PRF / A04011023OM
- Keywords
- ALB-PRF, intrabony defect, periodontitis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 24 Jan 2025 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
The objective of study also is to assess radiographic linear defect depth, and radiographic defect bone density following the application of liquid Platelet-Rich Fibrin (PRF) mixed with denaturated Albumin gel (ALB-PRF) or with bone allograft in periodontal intrabony defects.
Patients and methods: 28 patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University according to Pre-operative CBCT that will be used to evaluate the bone destruction pattern. According to the techniques that used in the treatment of periodontal bony defect, the participants will be randomly divided into 4 equal groups: Group I: will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF). Group II: will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. Group III: will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. Group IV: will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
Detailed description
28 patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University according to Pre-operative CBCT that will be used to evaluate the bone destruction pattern.
Sample size will be calculated using G-Power 3.1 for Mac with (α = 0.05, and power = 0.95). One-way ANOVA test will be used and effect size of (0.7) based on the anticipated mean difference of the efficacy of new generation platelet-rich fibrin according Nagy et.al 2021. The total sample size of the four groups will be 28 patients.
Inclusion criteria:
- periodontits stage III according to classification of periodontal and peri-implant disease and conditions (2018).
- Patient with two or three walls or combined bony defect.
- Favorable pattern of occlusion.
- Patient ability to comply with the required recall visits.
Exclusion Criteria:
- Local or systemic diseases that contraindicate surgery.
- Smokers
- Patients with parafunctional habits.
- Pregnancy or lactation.
- Diabetic patient.
- Osteoporosis.
- Immune-suppressed condition that may affect the outcome of the therapy.
- Study design:
According to the techniques that used in the treatment of periodontal bony defect, the participants will be randomly divided into 4 equal groups:
Group I: will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF).
Group II: will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects.
Group III: will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane.
Group IV: will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
II) Surgical Procedures ,liquid PRF and ALB-PRF preparation:
Patients will be premedicated by Amoxicillin 2 gm one hour before surgery as a prophylactic antibiotic, in addition patient will instructed to rinse with a 0.2% chlorhexidine mouth wash for 1 minute immediately prior to surgery.
All patients will be subjected to surgical procedure consisting of the injection of local anaesthetic Articaine hydrochloride 4% with epinephrine (1:100,000) followed by sulcular incision with 15c blade, reflection of a full thickness flap atraumaticlly , open flap debridement using periodontal curettes to remove all tissue tags and granulation tissue. Ethylenediaminetetraacetic acid (EDTA) will be applied to the root surface followed by rinsing with normal saline.
Liquid (PRF) and ALB-PRF Preparation:
As the protocol entails drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min.
The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form.
In group I, the defects will be treated with open flap debridement and DFDBA and mixed with liquid (PRF). In group II, the defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. In group III, the defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane. In group IV, the defects will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane. Vertical mattress suture with 5-0 suture will be used to close the wound.
Patients will be instructed to use 0.2% chlorhexidine gluconate mouth wash for 1 minute twice a day for 2 weeks, also maintained on amoxicillin 1gm twice a day for six days postoperatively and Ibuprofen 400 mg will be prescribed to be taken 2 to 4 times a day during meals as analgesic.
Clinical assessment: Pain and bruising will be obtain using Visual Analogue Scales (VAS) on days 0, 3, 5 and 7 post-operatively. While healing will be assess at days 2,7 and 14. The following periodontal indices will be assessed at baseline, 3 and 6 months: Plaque index (PI). Bleeding on Probing (BOP). Pocket depth (PD). Clinical Attachment Level (CAL). Radiographic Assessment: Using cone beam CT (CBCT) scan to assess linear bone defect depth and defect bone density at baseline and 6 months.
Statistical analysis: The data will be collected and statistical analysis will be done using SPSS(statistical package for social sciences) version 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- surgery and give medication
| Arm | Type | Receives |
|---|---|---|
| open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF) | Experimental | Procedure: Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRFwill include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF). |
| liquid (PRF) mixed with denatured albumin gel (ALB-PRF) injected in periodontal intrabony defects | Experimental | Procedure: defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defectswill include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. |
| open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. | Active comparator | Procedure: defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membranewill include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. |
| open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane. | Experimental | Procedure: open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane.will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Periodontist stage III according to classification of periodontal and peri-implant disease and conditions (2018).
- Patient with two or three walls or combined bony defect.
- Favourable pattern of occlusion.
- Patient ability to comply with the required recall visits.
Key exclusion criteria (7 listed)
- Local or systemic diseases that contraindicate surgery.
- Smokers
- Patients with parafunctional habits.
- Pregnancy or lactation.
- Diabetic patient.
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 |
|---|---|---|
| Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRFDrawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min. The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement and DFDBA and mixed with liquid (PRF) | Procedure or surgery | open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF) |
| defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defectsDrawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min. The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. | Procedure or surgery | liquid (PRF) mixed with denatured albumin gel (ALB-PRF) injected in periodontal intrabony defects |
| defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membraneDrawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min. The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane | Procedure or surgery | open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. |
| open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane.Drawing 9 ml of blood into plastic test tubes without anticoagulants and other additives. This is followed by a centrifugation process according to the protocol for liquid PRF by using centrifuge under 2700rpm for 8 min. The yellow top layer, formed upon centrifugation, consists of platelet-poor plasma that will be collect by a syringe in a volume of 2 ml, liquid PRF and buffy coat that will also be collected by a syringe in a volume of 4 ml. The Platelet-Poor plasma in the syringe will be transferred to a special machine that increases its temperature to 75°C for 10 minutes. ALB-PRF will be prepared by mixing the albumin gel with liquid concentrated growth factor including the buffy coat in a separate syringe by utilizing a female luer lock connector to obtain the injectable ALB-PRF in final ready form. in this group;, the defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane. | Procedure or surgery | open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane. |
Primary outcome
pocket depth
Time frame: pocket depth will be assessed at baseline, 3 and 6 months.
pocket depth: by placing dental probe between your teeth and gumline. Pockets are measured at several places in your upper and lower gums. In a healthy mouth, the pocket depth is usually between 1 and 3 millimetres (mm). Pockets deeper than 4 mm may indicate periodontitis
Plaque index
Time frame: At baseline ,3and 6 months
Evaluation of existence plaque in all around tooth aspects
Bleeding on Probing
Time frame: At baseline ,3 and 6months.
Evaluation of existence Bleeding during gentle periodontal probing.
Clinical Attachment Level
Time frame: At baseline ,3 and 6 months.
To assess the clinical attachment level.
4 secondary outcomes
Pain score
Time frame: At day 0,3,5 and 7 post-operatively. While healing will be assess at days 2,7 and 14
Alveolar ridge width (buccolingual).
Time frame: At base line and 6 months starting from base line.
Alveolar ridge height (apicocronal)
Time frame: At base line and 6 months starting from base line.
Bone density
Time frame: At base line and 6 months starting from base line.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No. after Completing the study ; the data will be available when requested
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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.
Dhaidan Naif Alshammari, Bachelor principal investigator
faculty of dentistry Mansoura 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 Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF, defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects and defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane in people with Periodontal Bone Loss and Periodontitis Stage III, run by Mansoura 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 7 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: enrolling by invitation, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
pocket depth (time frame: pocket depth will be assessed at baseline, 3 and 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 29 Jan 2025.