THBC/CGF for Alveolar Bone Regeneration: A Real-World Study

NCT07779421 | Recruiting

• 1 other identifier: 2024Clin004
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss; Tooth, Impacted; Alveolar Ridge Resorption After Extraction

Outcome Measures

Primary Outcomes (10)

• 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).

  7 days after surgery

• 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.

  Pre-operative, 3 months post-operative，6 months post-operative

• 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.

  Pre-operative; 3 months post-operative，6 months post-operative

• 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.

  Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgery

• Mouth Opening Width（Millimeters）

  Maximum interincisal distance (between the incisal margins of the upper and lower incisors) measured using standard calipers.

  Preoperative，1 day after surgery, 3 days after surgery, 7 days after surgery

• Postoperative pain (VAS score)

  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.

  1 day after surgery, 3 days after surgery, 7 days after surgery, 14 days after surgery

• Swelling degree（millimeter）

  Facial swelling measured as the distance from the tragus to the corner of the mouth on the extraction side, using a soft tape measure.

  Preoperative, 1 day postoperative, 3 days postoperative, 7 days postoperative

• Second Molar Probing Depth (Mean of Three Sites)

  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.

  Preoperative, 14 days postoperative, 3 months postoperative

• Second Molar Probing Tenderness（Ordinal category ）

  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.

  Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgery

• Postoperative Bleeding

  Presence of active bleeding from the extraction wound and presence of blood clot formation assessed at 30 minutes postoperatively. Recorded as present/absent.

  30 minutes after surgery

Study Arms (4)

THBC+CGF Composite

EXPERIMENTAL

Following extraction of the patient's mandibular third molar, immediate placement of a THBC/CGF composite filling was performed. Autologous venous blood was centrifuged, and the resulting CGF clot was compressed into a CGF membrane using specialised instruments. This membrane was mixed with 0.5 mL of THBC solution and injected into the extraction socket. The mixture gelled at 37 degrees Celsius, with a gelation time of less than or equal to 1 minute. Routine infection prevention measures were implemented postoperatively.

Combination Product: Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor

THBC

ACTIVE COMPARATOR

Following extraction of the patient's mandibular third molar, 0.5 mL of THBC was injected into the extraction socket and allowed to gel at 37 degrees Celsius (gelation time less than or equal to 1 minute). Routine infection prevention measures were implemented postoperatively.

Device: Temperature-sensitive hydroxybutyl chitosan

CGF

ACTIVE COMPARATOR

Immediately prior to surgery, venous blood is drawn from the patient and centrifuged without delay. Upon completion of preparation, the resulting CGF clot is compressed into a CGF membrane using specialised instruments. This CGF membrane is implanted directly into the extraction socket within 30 minutes of preparation to cover the bone defect area.Routine infection prevention measures were implemented postoperatively.

Biological: Autologous Concentrated Growth Factor

No Filling

SHAM COMPARATOR

Natural healing after tooth extraction: The extraction socket is filled solely by a blood clot without any implanted biomaterials. Routine infection prevention measures were implemented postoperatively.

Other: Natural Healing without Biomaterial Intervention

Interventions

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.

THBC+CGF Composite

Temperature-sensitive hydroxybutyl chitosan DEVICE

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.

THBC

Autologous Concentrated Growth Factor BIOLOGICAL

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).

CGF

Natural Healing without Biomaterial Intervention OTHER

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.

No Filling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stomatological Hospital Affiliated with Fujian Medical University: lead

Study Sites (1)

Stomatological Hospital Affiliated with Fujian Medical University

Fuzhou, Fujian, 350002, China

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss; Tooth, Impacted

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Ye Wu, Ph.D.

  Stomatological Hospital Affiliated with Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 21, 2026
• Study Start: August 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

CN (1)