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NCT Number: NCT06798116

Treatment of Periodontal Intrabony Defects With Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB_PRF)

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry Mansoura university

Al Mansurah, 35516, Egypt

About this study

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.

I) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF

Procedure

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 defects

Procedure

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 membrane

Procedure

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

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.

Primary outcomes

  1. 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

  2. Plaque index

    Time frame: At baseline ,3and 6 months

    Evaluation of existence plaque in all around tooth aspects

  3. Bleeding on Probing

    Time frame: At baseline ,3 and 6months.

    Evaluation of existence Bleeding during gentle periodontal probing.

  4. Clinical Attachment Level

    Time frame: At baseline ,3 and 6 months.

    To assess the clinical attachment level.

Secondary outcomes

  1. Pain score

    Time frame: At day 0,3,5 and 7 post-operatively. While healing will be assess at days 2,7 and 14

    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).

  2. Alveolar ridge width (buccolingual).

    Time frame: At base line and 6 months starting from base line.

    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.

  3. Alveolar ridge height (apicocronal)

    Time frame: At base line and 6 months starting from base line.

    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.

  4. Bone density

    Time frame: At base line and 6 months starting from base line.

    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).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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)

Acronym: ALB-PRF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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