Alveolar Bone Loss, Alveolar Ridge Resorption After Extraction, Tooth, Impacted
Conditions
Brief summary
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.
Detailed description
This study is a prospective observational investigation conducted in a real-world clinical setting. Its objective is to systematically evaluate the clinical efficacy and bone regeneration capacity of a novel composite material, thermosensitive hydroxybutyl chitosan (THBC) loaded with concentrated growth factor (CGF), in the clinical efficacy and bone regenerative capacity for restoring mesial bone defects in second molars following mandibular impacted third molar extraction. The study will enroll patients requiring extraction of mandibular mesial or lower impacted third molars. All participants will select different bone repair options based on clinical circumstances and personal preference, including the THBC+CGF experimental group, autogenous bone graft group, THBC group, CGF group, collagen sponge group, and unfilled control group. Baseline data and intraoperative details will be comprehensively described.
Interventions
COMBINATION_PRODUCTTemperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor
* 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.
DEVICETemperature-sensitive hydroxybutyl chitosan
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.
BIOLOGICALAutologous Concentrated Growth Factor
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).
OTHERNatural Healing without Biomaterial Intervention
After 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.
Sponsors
Stomatological Hospital Affiliated with Fujian Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * 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). *
Exclusion criteria
* 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. * Smoking \> 15 cigarettes per day. * Subjects with mental or neurological disorders, or otherwise unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alveolar Bone Height（Millimeters） | Pre-operative; 3 months post-operative，6 months post-operative | 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. |
| 7-day postoperative healing score | 7 days after surgery | 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). |
| Alveolar Bone Width（ Millimeters） | Pre-operative, 3 months post-operative，6 months post-operative | 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. |
| Second Molar Mobility (Modified Miller Grade) | Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgery | 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. |
| Mouth Opening Width（Millimeters） | Preoperative，1 day after surgery, 3 days after surgery, 7 days after surgery | Maximum interincisal distance (between the incisal margins of the upper and lower incisors) measured using standard calipers. |
| Postoperative pain (VAS score) | 1 day after surgery, 3 days after surgery, 7 days after surgery, 14 days after surgery | Patient-reported pain intensity on a 10-point visual analogue scale (VAS) with verbal descriptors: 0 = no pain; 1-3 = mild pain, not interfering with sleep; 4-6 = moderate pain, mildly interfering with sleep; 7-9 = severe pain, preventing sleep and requiring medication; 10 = worst possible pain. |
| Swelling degree（millimeter） | Preoperative, 1 day postoperative, 3 days postoperative, 7 days postoperative | Facial swelling measured as the distance from the tragus to the corner of the mouth on the extraction side, using a soft tape measure. |
| Second Molar Probing Depth (Mean of Three Sites) | Preoperative, 14 days postoperative, 3 months postoperative | Probing depth (PD) recorded at three sites of the second molar periodontium (buccal distal-medial, mid-distal, and lingual distal-medial) using a periodontal probe. The final reported value will be the mean of the three site measurements. PD is defined as the distance from the free gingival margin to the bottom of the periodontal pocket. |
| Second Molar Probing Tenderness（Ordinal category ） | Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgery | Vertical percussion of the occlusal surface of the second molar (M2) using the handle of a metal dental mirror, compared with the contralateral healthy tooth. Response graded as: (-) = no discomfort, identical to control; (±) = abnormal sensation/soreness, not clearly pain; (+) = clear pain, tolerable; (++) = sharp pain provoking avoidance; (+++) = severe pain, refusal of further examination. |
| Postoperative Bleeding | 30 minutes after surgery | Presence of active bleeding from the extraction wound and presence of blood clot formation assessed at 30 minutes postoperatively. Recorded as present/absent. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYe Wu, Ph.D.
Stomatological Hospital Affiliated with Fujian Medical University
Outcome results
None listed