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AzTrials

Alveolar Socket PreservationAlb-PRFNCT06757218

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).

A study testing empty socket, Autogenous Dentin Graft with Platelet Rich Fibrin and Autogenous Dentin Graft with Albumin Platelet Rich Fibrin in people with Alveolar Socket Preservation, run by Kafrelsheikh University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Alveolar Socket Preservation
What is being tested?
empty socket, Autogenous Dentin Graft with Platelet Rich Fibrin and Autogenous Dentin Graft with Albumin Platelet Rich Fibrin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jun 2025to 30 Aug 2026
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Kaferelsheikh University

    Kafr ash Shaykh, Kafrelsheikh, 6860404

    Recruiting

Other trials in Egypt

About this study

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.

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.

Read the 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.
  1. Study Group 1:
  • 20 sockets receiving autogenous dentin graft and platelet-rich fibrin (PRF) block.
  1. 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.
  1. Mouthwash: Use a 0.12% chlorhexidine mouthwash for gentle rinsing, twice daily for 2 weeks.
  2. Postoperative Issues: Contact your physician immediately if you experience abnormal bleeding.
  3. Suture Removal: Sutures will be removed 2 weeks after surgery.
  4. Follow-up: Schedule a follow-up appointment 6 months after the procedure.
Being tested
empty socket, Autogenous Dentin Graft with Platelet Rich Fibrin, Autogenous Dentin Graft with Albumin Platelet Rich Fibrin
Keywords
Autogenous Dentin Graft, Albumin Platelet Rich Fibrin, Platelet Rich Fibrin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • empty socketOther

    Patients will be left socket empty without any graft materials for spontaneous healing process after tooth extraction

  • Autogenous Dentin Graft with Platelet Rich FibrinProcedure or surgery

    Patients will be inserting autogenous dentin graft and platelet rich fibrin in the socket after extraction.

  • Autogenous Dentin Graft with Albumin Platelet Rich FibrinProcedure or surgery

    Patients will be inserting autogenous dentin graft and Albumin Platelet Rich Fibrin in the socket after extraction.

Study groups in NCT06757218
Study groupRoleWhat they receive
empty socketOtherNot described
Receives: Other: empty socket
Autogenous Dentin Graft with Platelet Rich FibrinActive comparatorNot described
Autogenous Dentin Graft with Albumin Platelet Rich FibrinExperimentalNot described
Receives: Procedure: Autogenous Dentin Graft with Albumin Platelet Rich Fibrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 baseline immediately after extraction and after six months

  2. 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 baseline immediately after extraction and after six months

  3. 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 baseline immediately after extraction and after six months

Secondary outcomes (3)
  1. Pain scores

    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 24 hours, 3 days, 7 days and 14 days postoperative

  2. Patient satisfaction

    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).

    Measured: at 24 hours, 3 days, 7 days,14 days postoperative and after six months

  3. Keratinized tissue width

    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).

    Measured: at baseline before extraction and after six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2025
  2. Study start1 Jun 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

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
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06757218
Sponsor's protocol ID
KFSIRB200-471
Acronym
Alb-PRF
Status last verified
Jul 2025
First submitted
26 Dec 2024
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing empty socket, Autogenous Dentin Graft with Platelet Rich Fibrin and Autogenous Dentin Graft with Albumin Platelet Rich Fibrin in people with Alveolar Socket Preservation, run by Kafrelsheikh 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Jul 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?

Contact MUATH ATIF HASSAN (+201507571780, muath_01pg@den.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alveolar ridge width (buccolingual). (time frame: at baseline immediately after extraction and after six months). The study lists 3 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 10 Jul 2025.

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