Kaferelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 6860404, Egypt
Location status: Recruiting
NCT Number: NCT06757218
The study focuses on the impact of tooth loss on alveolar bone, which shrinks significantly within the first three months. To prevent this, strategies like alveolar ridge preservation are used.
Autogenous dentin, taken from the patient, supports healing and bone regrowth. Platelet-rich fibrin (PRF), made from the patient's blood, enhances healing and bone density by releasing growth factors.
A new technique combining L-PRF with albumin creates a stable healing membrane that provides a steady release of growth factors. Overall, these methods improve recovery after tooth extractions and prepare sites for future dental work.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Kafr ash Shaykh, Kafrelsheikh, 6860404, Egypt
Location status: Recruiting
Study Design and Randomization:
Groups:
Materials and Preparation
The tooth that has been removed will be thoroughly cleaned of any leftover periodontal ligaments, cementum, soft tissue connections, decay, or restorations using a high-speed fine finishing stone along with saline irrigation. Using sterile endodontic files, the pulp chamber will thoroughly be cleaned. Subsequently, the tooth will be ground using a Dentin grinding device to achieve a particle size between 300-1200 μm .The Autogenous Dentin Graft particles will be prepared by demineralizing tooth graft particles through immersion in 0.6N hydrochloric acid for 30 minutes. This will be followed by two rinses with saline and drying with sterile gauze.
A sample of 10 ml intravenous blood will be collected from the median antecubital vein of the patient. This blood will be placed in 10 ml glass tubes without any additives and will be immediately centrifuged at 3000 RPM for 10 minutes at room temperature. The tube will be separated into three parts, namely, a packed red blood cell at the bottom, acellular plasma at the top, and the PRF clot in between. The PRF clot will be extracted from the tube with the help of sterile tweezers and a surgical blade and then placed in the PRF box to obtain a membrane.
Nine milliliters of blood in plastic tubes will be centrifuged at 700 g for 8 minutes using an Eppendorf centrifugate. The upper layer (platelet-poor plasma layer) was collected in 2-mL syringes and heated at 75°C for 10 minutes to create denatured albumin (albumin gel). Following heating, the albumin gel was allowed to cool to room temperature for 10 minutes. Then, liquid PRF including remaining cells and growth factor found within the buffy coat layer was thereafter mixed back together with the cooled albumin gel to form Alb-PRF using a female-female luer lock connector. This combination allowed that both the lower-resorption properties of the albumin gel along with the higher cell content and growth factor content of the liquid PRF layer to be remixed. The injectable Alb-PRF gels will then be transferred into culture plate forming a gelated ALB-PRF membrane.
Preoperative Evaluation:
Clinical Procedure:
Post-Extraction Treatment
Use surgical curved scissors to cut the two L-PRF membranes into very small pieces, mix chopped membranes and dentin substitute in Ti-dish (2 membranes / 0.5g dentin graft), Add 1 cc of liquid fibrinogen to the homogeneous mixture and gently stir for 5 to 10 seconds while shaping it into the desired form, Fibrinogen will clot into fibrin within a few minutes and trap the biomaterial to form a L-PRF block. the graft will be placed into the socket and will be Covered with a PRF membrane and secured with a single crisscross 5-0 polypropylene suture.
Postsurgical Care Instructions:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be left socket empty without any graft materials for spontaneous healing process after tooth extraction
Patients will be inserting autogenous dentin graft and platelet rich fibrin in the socket after extraction.
Patients will be inserting autogenous dentin graft and Albumin Platelet Rich Fibrin in the socket after extraction.
Time frame: at baseline immediately after extraction and after six months
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.
Time frame: at baseline immediately after extraction and after six months
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.
Time frame: at baseline immediately after extraction and after six months
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).
Time frame: at 24 hours, 3 days, 7 days and 14 days postoperative
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).
Time frame: at 24 hours, 3 days, 7 days,14 days postoperative and after six months
Will use Surveys/Questionnaires to assess patient satisfaction regarding treatment outcomes and experiences. The patients will report their satisfaction score directly through satisfaction score (between 0 and 4; 0: Very satisfied, 1: Satisfied, 2: Neither satisfied nor dissatisfied, 3: Dissatisfied, 4: Very dissatisfied).
Time frame: at baseline before extraction and after six months
Will be assessed through probing techniques before and 6 months after surgical intervention.
The measurements will be taken at the vertical distance from a line connecting the two neighboring teeth at the CEJs to the free gingival margin (FGM) using a UNC 15 probe (Nordent Manufacturing Inc., IL, USA).
Contact information is provided by the study sponsor or research team.
Kafrelsheikh University
Other
Comparison of Autogenous Dentin Graft With Albumin Platelet Rich Fibrin Versus Autogenous Dentin Graft With Platelet Rich Fibrin in Alveolar Socket Preservation: A Randomized Controlled Clinical Trial.
Acronym: Alb-PRF
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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