Evaluation of Stem Cell Exosomes Versus Platelet-Rich Fibrin in Tooth Extraction Socket Healing
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-45
SponsorAl Salam University
About this trial
This study evaluates two different treatments used to help the jawbone heal after a tooth is removed. When a tooth is extracted, the surrounding bone often shrinks, which can make it difficult to place dental implants later. Currently, doctors often use Platelet-Rich Fibrin (PRF), which is made from the patient's own blood, to help the area heal.
This research compares PRF to a newer treatment using "exosomes" derived from stem cells. Exosomes are tiny particles that carry signals to tell the body to repair tissue and grow new bone. The goal of this study is to see if these exosomes work better than PRF at keeping the bone strong and thick after an extraction. Researchers will use specialized X-rays (CBCT) to measure the bone three months after the procedure to see which treatment provided better results.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged between 20 and 45 years.
Patients requiring a single tooth extraction of a non-infected tooth in the aesthetic zone (incisors, canines) or premolar area.
Presence of adjacent teeth to the extraction site.
Adequate oral hygiene (Plaque Index < 20%).
Disqualifiers
Patients with systemic diseases that contraindicate oral surgery or interfere with bone healing (e.g., uncontrolled diabetes, osteoporosis, hyperparathyroidism).
History of head and neck radiation therapy or bisphosphonate medication use.
Active infection or acute abscess at the extraction site.
Heavy smokers (more than 10 cigarettes per day).
Trial design
Design model
Parallel
Treatments tested in this trial
MSC-Derived Exosomes
Biological/VaccineA cell-free regenerative therapy consisting of purified exosomes derived from mesenchymal stem cells, applied to promote bone healing and reduce ridge resorption.
Platelet-rich fibrin (PRF)
Biological/VaccineA second-generation platelet concentrate prepared by centrifuging the patient's own blood at the time of surgery to create a fibrin clot rich in growth factors.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental Group (MSC-Exosomes)Experimental treatment 1 intervention
Group B: PRF GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Alveolar Bone Density (Hounsfield Units)
Bone density will be measured using Cone Beam Computed Tomography (CBCT). The mean Hounsfield Units (HU) will be calculated in the center of the extraction socket to evaluate the quality of new bone formation.
Time frame
Baseline (Day of surgery) and 3 months post-operatively.Secondary outcomes
1
Alveolar Ridge Dimensional Changes (Height and Width)
The horizontal width and vertical height of the alveolar ridge will be measured in millimeters (mm) using standardized cross-sectional CBCT images to assess the amount of bone resorption or preservation.
Time frame
Baseline (Day of surgery) and 3 months post-operatively.2
Soft Tissue Healing Score (Landry Index)
Clinical assessment of the surgical site using the Landry, Turnbull, and Heasman Index. The scale ranges from 1 (very poor) to 5 (excellent) based on tissue color, response to palpation, and presence of granulation tissue.
Time frame
7 days and 14 days post-operatively.3
Patient-Reported Postoperative Pain (VAS Score)
Pain levels will be self-reported by patients using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame
Daily for the first 7 days post-operatively.Sponsors and contacts
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Source ClinicalTrials.gov