Third Molar ExtractionNCT05971342
The Safety and Efficacy of Alveolar Bone Defect Repair Induced by Gelatin Sponge-loaded Apoptotic Vesicle Complex
A study testing Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®) and Gelatin sponge only （Kuaikang®) in people with Third Molar Extraction, run by Fifth Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Third Molar Extraction
- What is being tested?
- Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®) and Gelatin sponge only （Kuaikang®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510055
About this study
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
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.
Read the 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.
- Conditions
- Third Molar Extraction
- Being tested
- Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®), Gelatin sponge only （Kuaikang®)
- Keywords
- Third Molar Extraction, Alveolar Bone Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)Drug
Also called Gelatin sponge （Kuaikang®）. Apoptotic vesicles are derived from umbilical cord mesenchymal stem cells
The experimental group
Gelatin sponge only （Kuaikang®)Drug
Also called Gelatin sponge （Kuaikang®）
The positive control group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Gelatin sponge only （Kuaikang®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Hemostatic time after third molar extraction
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.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start20 Aug 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Molar ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971342
- Sponsor's protocol ID
- Mao Xue Li
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05971342
- Acronym / sponsor ID
- Mao Xue Li
- Conditions
- Third Molar Extraction
- Keywords
- Third Molar Extraction, Alveolar Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fifth Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelatin sponge-loaded apoptotic vesicle complex | Experimental | Drug: Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)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. |
| Gelatin sponge only | Active comparator | Drug: Gelatin sponge only （Kuaikang®)A piece of gelatin sponge（Kuaikang®）was placed in an extraction socket after tooth extraction. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)Also: Gelatin sponge （Kuaikang®）. Apoptotic vesicles are derived from umbilical cord mesenchymal stem cellsThe experimental group | Drug | Gelatin sponge-loaded apoptotic vesicle complex |
| Gelatin sponge only （Kuaikang®)Also: Gelatin sponge （Kuaikang®）The positive control group | Drug | Gelatin sponge only |
Primary outcome
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.
1 secondary outcome
Hemostatic time after third molar extraction
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®) and Gelatin sponge only （Kuaikang®) in people with Third Molar Extraction, run by Fifth Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.