THBC/CGF for Alveolar Bone Regeneration: A Real-World Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorStomatological Hospital Affiliated with Fujian Medical University
About this trial
This study aims to combine real-world research with relevant bone repair materials and techniques to improve alveolar bone resorption in extraction sockets following impacted wisdom tooth removal, while achieving effective bone preservation or promoting bone regeneration. All eligible cases within specified parameters will be included in the clinical study scope. Based on real-world clinical data, we will proactively collect postoperative clinical examination findings and imaging data. Statistical analysis will be performed on clinical outcomes and follow-up data from patients undergoing mandibular impacted M3 extraction. The study aims to clarify the therapeutic efficacy of the thermosensitive hydroxyethylchitosan-loaded concentrated growth factor group in repairing mesial bone defects of M2s following M3 extraction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preoperative CBCT imaging confirming mandibular third molars (M3s) with low to moderate impaction according to the Pell and Gregory classification, and not in the acute inflammatory stage.
Ipsilateral mandibular second molars (M2s) with retention value and no indication for extraction.
Patients able to provide written informed consent and willing to comply with the scheduled follow-up visits.
Age between 18 and 60 years (inclusive).
Disqualifiers
Presence of systemic diseases or other contraindications to tooth extraction surgery.
Known or suspected current malignancy.
History of radiation therapy to the head and neck region.
History of chemotherapy within 5 years prior to surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor
Combination product* THBC Component: Its key component is hydroxybutyl chitosan. The product is supplied as a clear or light yellow, easily flowing liquid at storage temperature (2-8 degrees Celsius) and undergoes a sol-gel transition to form a transparent or semi-transparent gel at body temperature (37 +/- 2 degrees Celsius). The product is composed of hydroxybutyl chitosan, glycerol, and purified water. It is designed to provide a physical barrier, create a moist wound-healing environment, and alleviate pain. * CGF Component: Concentrated Growth Factor (CGF) is a third-generation autologous platelet concentrate obtained from the patient's own venous blood through a specific centrifugation process. It presents as a dense, three-dimensional fibrin matrix rich in platelets, leukocytes, cytokines, and growth factors (such as PDGF, TGF-beta, VEGF). * Composite Process: Mixed under sterile conditions, injection flow rate less than or equal to 0.5 mL/s.
Temperature-sensitive hydroxybutyl chitosan
DeviceIts key component is hydroxybutyl chitosan. The product is supplied as a clear or light yellow, easily flowing liquid at storage temperature (2-8 degrees Celsius) and undergoes a sol-gel transition to form a transparent or semi-transparent gel at body temperature (37 +/- 2 degrees Celsius). The product is composed of hydroxybutyl chitosan, glycerol, and purified water. It is designed to provide a physical barrier, create a moist wound-healing environment, and alleviate pain.
Autologous Concentrated Growth Factor
Biological/VaccineConcentrated Growth Factor (CGF) is a third-generation autologous platelet concentrate obtained from the patient's own venous blood through a specific centrifugation process. It presents as a dense, three-dimensional fibrin matrix rich in platelets, leukocytes, cytokines, and growth factors (such as PDGF, TGF-beta, VEGF).
Natural Healing without Biomaterial Intervention
Other interventionAfter tooth extraction, gently scraping the bone wall induces bleeding, allowing a natural blood clot to form. Within 30 minutes postoperatively, ensure the clot fills more than 90 percent of the socket without applying experimental biomaterials.
Treatment groups
136 Participants
are divided into 4 treatment groupsGroup A: THBC+CGF CompositeExperimental treatment 1 intervention
Group B: THBCActive comparator 1 intervention
Group C: CGFActive comparator 1 intervention
Group D: No FillingSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
7-day postoperative healing score
Healing of the extraction wound and granulation tissue formation assessed at 7 days postoperatively. Scoring: 3 = complete healing (no gingival redness or swelling); 2 = fistula detected at the distal-middle area of the second molar or mild gingival redness/swelling without infection; 1 = poor healing or obvious redness/swelling without pus; 0 = presence of pus (infection).
Time frame
7 days after surgery2
Alveolar Bone Width（ Millimeters）
Width of the alveolar bone measured as the distance from the crest of the buccal alveolar ridge to the crest of the lingual alveolar ridge, using the CT scanner's built-in measurement software.
Time frame
Pre-operative, 3 months post-operative，6 months post-operative3
Alveolar Bone Height（Millimeters）
Height of the alveolar bone measured as the vertical distance from the highest point of the alveolar bone to the upper wall of the mandibular canal, using the CT scanner's built-in measurement software.
Time frame
Pre-operative; 3 months post-operative，6 months post-operative4
Second Molar Mobility (Modified Miller Grade)
Mobility of the second molar assessed using the modified Miller grading system with two standard metal dental instrument handles (e.g., mouth mirror handle and probe handle). Grade 0 = no mobility; Grade I = labial/lingual mobility \<1 mm; Grade II = labial/lingual mobility 1-2 mm; Grade III = labial/lingual mobility \>2 mm with vertical mobility.
Time frame
Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov