Clinical trial NCT05971342: The Safety and Efficacy of Alveolar Bone Defect Repair Induced by Gelatin Sponge-loaded Apoptotic Vesicle Complex
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Third Molar Extraction
Keywords: Third Molar Extraction
Alveolar Bone Regeneration
Lead sponsor: Fifth Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation
timeFrame: 3 months
Secondary outcomes:
measure: Hemostatic time after third molar extraction
timeFrame: 0 day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
state: Guang dong
Study officials:
References: