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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Third Molar Extraction
• Intervention / Treatment: Drug: Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®); Drug: Gelatin sponge only （Kuaikang®)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gelatin sponge-loaded apoptotic vesicle complex; 4 * 10^10 apoptotic vesicles derived from umbilical cord mesenchymal stem cells were loaded in a gelatin sponge（Kuaikang®）. A piece of gelatin sponge-loaded apoptotic vesicle complex was placed in an extraction socket after tooth extraction.	Drug: Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®); The experimental group; Other Names: Gelatin sponge （Kuaikang®）. Apoptotic vesicles are derived from umbilical cord mesenchymal stem cells
Active Comparator: Gelatin sponge only; A piece of gelatin sponge（Kuaikang®）was placed in an extraction socket after tooth extraction.	Drug: Gelatin sponge only （Kuaikang®); The positive control group; Other Names: Gelatin sponge （Kuaikang®）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Third Molar Extraction; Alveolar Bone Regeneration
• Other Study ID Numbers: Mao Xue Li

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No