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

NCT05971342 | Completed DMC

• 1 other identifier: Mao Xue Li
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Third Molar Extraction

Keywords

Third Molar Extraction; Alveolar Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hemostatic time after third molar extraction

  0 day

Study Arms (2)

Gelatin sponge-loaded apoptotic vesicle complex

EXPERIMENTAL

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®)

Gelatin sponge only

ACTIVE COMPARATOR

A piece of gelatin sponge（Kuaikang®）was placed in an extraction socket after tooth extraction.

Drug: Gelatin sponge only （Kuaikang®)

Interventions

Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®) DRUG

The experimental group

Also known as: Gelatin sponge （Kuaikang®）. Apoptotic vesicles are derived from umbilical cord mesenchymal stem cells

Gelatin sponge-loaded apoptotic vesicle complex

Gelatin sponge only （Kuaikang®) DRUG

The positive control group

Also known as: Gelatin sponge （Kuaikang®）

Gelatin sponge only

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-45 (including the boundary value)
• Patients who need to extract the bilateral mandible third molars
• Patients who voluntarily sign the informed consent form

You may not qualify if:

• 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
• The adjacent second molars have metal crowns or large amalgam restorations
• There is an uncontrollable pathological process in the patient's oral cavity
• Malnutrition (serum albumin concentration \<2 g/dl)
• Other systemic, infectious diseases and hereditary diseases, or patients in the acute inflammatory phase and acute exacerbation phase of chronic diseases
• Patients who are pregnant, lactating, or planning to become pregnant

Sponsors & Collaborators

• Fifth Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510055, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: August 2, 2023
• Study Start: August 20, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: June 10, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)