Post Extraction Changes After Alveolar Socket Preservation Using Autogenous Dentin Graft (ADG) Combined With Either Albumin Platelet-rich Fibrin (ALB-PRF) or Standard Platelet-rich Fibrin (PRF).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: empty socket, Autogenous Dentin Graft with Platelet Rich Fibrin, Autogenous Dentin Graft with Albumin Platelet Rich Fibrin.
- Who it may be relevant to
- Registry conditions: Alveolar Socket Preservation. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Detailed description
Study Design and Randomization:
* Patients classified randomly using computer-generated randomization. * Performed by the supervisor. * Three main study groups established. * Decision for treatment group assignment based on randomized numbers in opaque sealed envelopes, picked by the supervisor.
Groups:
1. Control Group:
* 20 sockets with empty sockets to allow spontaneous healing post-extraction. 2. Study Group 1:
* 20 sockets receiving autogenous dentin graft and platelet-rich fibrin (PRF) block. 3. Study Group 2:
* 20 sockets receiving autogenous dentin graft and Albumin PRF (Alb-PRF) block.
Materials and Preparation
1. Autogenous Dentin Graft:
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. 2. Platelet-Rich Fibrin (PRF):
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. 3. Albumin Platelet Rich Fibrin (Alb-PRF):
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 examination to confirm eligibility. * Full mouth charting for periodontal evaluation. * Patient education on plaque control and oral hygiene. * Supra \& subgingival debridement performed.
Clinical Procedure:
* Pre-extraction rinse with 0.12% chlorhexidine. * Local anesthesia using 2% mepivacaine HCL with levonordefrin. * Tooth extraction via minimally traumatic flapless technique. * Evaluation of extraction socket integrity.
Post-Extraction Treatment
* Control Group: Left the socket empty for healing. * For the Autogenous Dentin Graft with Platelet Rich Fibrin Block group:
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.
\- For the Autogenous Dentin Graft with Albumin Platelet Rich Fibrin group: Mixing the autogenous dentin particles with ALB-PRF in a 1:1 ratio to create a cohesive graft material (dentin block). The graft material is now fully prepared for use. the graft will be placed into the socket and will be Covered with a gelated ALB-PRF membrane. sutured by a single crisscross 5-0 polypropylene suture.
Postsurgical Care Instructions:
1. Avoid Trauma: Do not disturb the surgical site or sutures. 2. Diet: Avoid hot food and refrain from rinsing your mouth. 3. Oral Hygiene: Do not brush the surgical area for 2 weeks; gentle brushing can resume afterward. 4. Medications:
* Take Amoxicillin 500mg three times daily for 10 days or Doxycycline 100mg twice daily if allergic to penicillin. * Use Ibuprofen 600mg for severe pain as needed. 5. Mouthwash: Use a 0.12% chlorhexidine mouthwash for gentle rinsing, twice daily for 2 weeks. 6. Postoperative Issues: Contact your physician immediately if you experience abnormal bleeding. 7. Suture Removal: Sutures will be removed 2 weeks after surgery. 8. Follow-up: Schedule a follow-up appointment 6 months after the procedure.
Interventions
- Other empty socket
Patients will be left socket empty without any graft materials for spontaneous healing process after tooth extraction - Procedure Autogenous Dentin Graft with Platelet Rich Fibrin
Patients will be inserting autogenous dentin graft and platelet rich fibrin in the socket after extraction. - Procedure Autogenous Dentin Graft with Albumin Platelet Rich Fibrin
Patients will be inserting autogenous dentin graft and Albumin Platelet Rich Fibrin in the socket after extraction.
Primary outcome measures
- Alveolar ridge width (buccolingual). [Time frame: at baseline immediately after extraction and after six months]
- Alveolar ridge height (apicocronal) [Time frame: at baseline immediately after extraction and after six months]
- Bone density [Time frame: at baseline immediately after extraction and after six months]
Secondary outcome measures (3)
- Pain scores [Time frame: at 24 hours, 3 days, 7 days and 14 days postoperative]
- Patient satisfaction [Time frame: at 24 hours, 3 days, 7 days,14 days postoperative and after six months]
- Keratinized tissue width [Time frame: at baseline before extraction and after six months]
Eligibility criteria
Inclusion criteria
- Medically free patients.
- Adult patients above 18 Years to 60 Years.
- Non-restorable tooth indicated for extraction.
- Posterior mandibular teeth.
- Inactive infection related to the tooth.
- Cooperative patients.
Exclusion criteria
- Presence of any systemic disease that could influence the outcome of the therapy.
- Presence of any risk factor (smoker, pregnant and lactating patients).
- Patients with bone diseases.
- Patients with poor oral hygiene.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kaferelsheikh University — Kafr ash Shaykh
Identifiers
NCT: NCT06757218 · KFSIRB200-471