Clinical trial NCT06757218: The Primary Aim is to Compare the Outcomes of Autogenous Dentin Graft (ADG) Combined with Either Albumin Platelet-rich Fibrin (ALB-PRF) or Standard Platelet-rich Fibrin (PRF) in Terms of Bone Preservation and Healing in the Alveolar Socket.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Socket Preservation
Keywords: Autogenous Dentin Graft
Albumin Platelet Rich Fibrin
Platelet Rich Fibrin
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical study, Double blinded (patients and biostatistician) with allocation ratio 1:1:1 using 3 - arm parallel groups (2 experimental and control).
Primary purpose: TREATMENT

Brief summary: 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 patients with empty sockets to allow spontaneous healing post-extraction.
2. Study Group 1:

   * 20 patients receiving autogenous dentin graft and platelet-rich fibrin (PRF) block.
3. Study Group 2:

   * 20 patients 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.

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.

Primary outcomes:
measure: Alveolar ridge width (buccolingual).
timeFrame: At base line and 6 months starting from base line.
measure: Alveolar ridge height (apicocronal)
timeFrame: At base line and 6 months starting from base line.
measure: Bone density
timeFrame: At base line and 6 months starting from base line.
Secondary outcomes:
measure: Pain scores
timeFrame: At base line.
measure: Patient satisfaction
timeFrame: At base line and 6 months starting from base line.
measure: Keratinized tissue width
timeFrame: At base line and 6 months starting from base line.
Other outcomes:
Locations:
city: Kafr El-Sheikh
country: Egypt
facility: Kaferelsheikh University
Study officials:
affiliation: Kaferelsheikh University
name: Enas Ahmed Elgendy, PhD
role: STUDY_DIRECTOR
References: