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Completed

NCT Number: NCT05971342

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510055, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Gelatin sponge-loaded apoptotic vesicle complex(Kuaikang®)

Drug

The experimental group

Other names: Gelatin sponge (Kuaikang®). Apoptotic vesicles are derived from umbilical cord mesenchymal stem cells

Gelatin sponge only (Kuaikang®)

Drug

The positive control group

Other names: Gelatin sponge (Kuaikang®)

Primary outcomes

  1. Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation

    Time frame: 3 months

    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.

Secondary outcomes

  1. Hemostatic time after third molar extraction

    Time frame: 0 day

    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.

Sponsors and collaborators

Lead sponsor

Fifth Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2023
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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