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

Fifth Affiliated Hospital of Guangzhou Medical University

Status: Completed

Conditions: Third Molar Extraction

Treatments: Drug: Gelatin sponge only （Kuaikang®); Drug: Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)

Study type: Interventional

Funder types: Other

Identifiers

NCT05971342

Mao Xue Li

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

Gelatin sponge-loaded apoptotic vesicle complex

Experimental group

Description:

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.

Treatment:

Drug: Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)

Gelatin sponge only

Active Comparator group

Description:

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

Treatment:

Drug: Gelatin sponge only （Kuaikang®)