The Safety and Efficacy of Alveolar Bone Defect Repair Induced by Gelatin Sponge-loaded Apoptotic Vesicle Complex

Third Molar Extraction Clinical Trial

Official title:

A Two-arm Clinical Study to Evaluate the Safety and Efficacy of Gelatin Sponge-loaded Apoptotic Vesicle Complex for Alveolar Bone Defect Repair After Mandibular Third Molar Extraction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05971342
• Other study ID #: Mao Xue Li
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 20, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: Fifth Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Distal bone loss of the second molar due to extraction of the third molar is one of the most common pathological conditions that results in tooth loss of second molar. However, regeneration of functional alveolar bone has proved difficult. Therefore, the investigators conduct a two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction.

Description:

This study is a single-center, prospective, two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. One socket for each participant in this study will receive gelatin sponge-loaded apoptotic vesicle complex after third molar extraction and socket debridement. The other side of socket for each participant in this study will receive commercial gelatin sponge after the same surgery. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 1 year.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18-45 (including the boundary value)

2. Patients who need to extract the bilateral mandible third molars

3. Patients who voluntarily sign the informed consent form

Exclusion Criteria:

1. The adjacent second molars in the patient's oral cavity are affected by pulp injury or insufficient endodontic treatment, or show tooth fracture, or have a degree of motion of 3 degrees

2. The adjacent second molars have metal crowns or large amalgam restorations

3. There is an uncontrollable pathological process in the patient's oral cavity

4. Malnutrition (serum albumin concentration <2 g/dl)

5. Other systemic, infectious diseases and hereditary diseases, or patients in the acute inflammatory phase and acute exacerbation phase of chronic diseases

6. Patients who are pregnant, lactating, or planning to become pregnant

Related Conditions & MeSH terms

• Third Molar Extraction

Intervention

Drug:
• Gelatin sponge-loaded apoptotic vesicle complex(Kuaikang®)
The experimental group
• Gelatin sponge only (Kuaikang®)
The positive control group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital of Guangzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation	CBCT is a cone-beam projection computerized reconstruction tomography device. Its principle is that the X-ray generator uses a low radiation dose to make a circular DR (digital projection) around the projection body. Then the data obtained in the "intersection" after digital projection around the projection body multiple times is "reconstructed" in the computer to obtain a three-dimensional image. CBCT can observe the three-dimensional level of bone regeneration, so as to calculate the bone volume fraction of the regenerated bone tissue.	3 months
Secondary	Hemostatic time after third molar extraction	After the third molar was completely extracted, commercial gelatin sponge or gelatin sponge loaded with apoptotic vesicle complex were placed in the socket. The time to hemostasis in the extraction socket was observed and recorded at the same time.	0 day