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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®) (Drug)
Gelatin sponge only
A piece of gelatin sponge（Kuaikang®）was placed in an extraction socket after tooth extraction.
Intervention: Gelatin sponge only （Kuaikang®) (Drug)
Outcomes
Primary Outcomes
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
- Hemostatic time after third molar extraction(0 day)