Concentrated Growth FactorNCT05938907
Effect of Concentrated Growth Factors on Healing of Apicomarginal Defects: a Prospective Study
A study testing concentrated growth factor, bone substitute and concentrated growth factor + bone substitute in people with Concentrated Growth Factor and Bone Substitute, run by West China Hospital at 1 site in China.
Trial summary
The persistent and chronic apical periodontitis has caused great difficulties for clinical physicians. Ensuring rapid and successful healing of the extensively damaged periapical region is a pressing issue that needs to be addressed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concentrated Growth Factor, Bone Substitute
- What is being tested?
- concentrated growth factor, bone substitute and concentrated growth factor + bone substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or above.
- Tooth with significant symptoms or with root apex bone tissue destruction that cannot be treated by non-surgical methods.
- The affected tooth is either an anterior tooth or a premolar.
- The size of the lesion during preoperative cone beam computed tomography (CBCT) coronal acquisition is at least 6 mm but not more than 12 mm.
- The affected tooth has undergone successful root canal treatment.
- CBCT shows intact lingual side bone plate in the apical region, with only buccal alveolar bone defect present.
- Good oral hygiene and compliance with medical instructions.
Who cannot join
- Severe periodontal destruction, with over 1/3 of the root length absorbed by alveolar bone.
- CBCT shows root fracture or root canal perforation.
- After root apex surgery, crown-root ratio ≤1:1.
- Presence of surgical contraindications, systemic and local factors that affect wound healing.
- Pregnant women and females planning to conceive within the next two years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
Wen Luo, 15103660395, luowen228@163.com
About this study
The persistent and chronic apical periodontitis has caused great difficulties for clinical physicians. Ensuring rapid and successful healing of the extensively damaged periapical region is a pressing issue that needs to be addressed. The treatment options include traditional apical surgery, simultaneous placement of bone powder and membrane after apical surgery, and simultaneous placement of sticky bone (bone powder mixed with concentrated growth factors gel) and membrane. However, high-quality evidence regarding these various treatment options is scarce. The purpose of this study is to compare the advantages and disadvantages of each treatment option, in order to guide clinical physicians in the application of apical surgery.
Read the detailed description
This prospective study will recruit 72 patients with chronic periapical periodontitis in their anterior teeth or premolars, all of which have received comprehensive root canal treatment. The patients will be randomly divided into four groups: Group A, which will undergo only apical surgery (including apicoectomy, inflammation debridement, and retrofilling of the root apex); Group B, which will undergo apical surgery plus bone powder; Group C, which will undergo apical surgery plus CGF (concentrated growth factors); and Group D, which will undergo apical surgery plus bone powder and CGF gel. Each group will consist of 18 patients, and all surgeries will be performed by the same experienced doctor. The participants will receive a 1-year follow-up with the assistance of a professional doctor, including questionnaire data and daily records of pain and swelling at 2, 6, and 12 hours and 7 days after the intervention. Cone-beam computed tomography (CBCT) images will also be taken before the surgery, immediately after the surgery, and at 2, 3, 4, 6, and 12 months post-surgery.
- Conditions
- Concentrated Growth Factor, Bone Substitute
- Being tested
- concentrated growth factor, bone substitute, concentrated growth factor + bone substitute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentrated growth factorOther
Implanting concentrated growth factor into the area of root apical bone defect
bone substituteOther
Implanting bone substitute into the area of root apical bone defect
concentrated growth factor + bone substituteCombination product
Implanting concentrated growth factor + bone substitute into the area of root apical bone defect
| Study group | Role | What they receive |
|---|---|---|
| only apical surgery group | No intervention | which will undergo only apical surgery (including apicoectomy, inflammation debridement, and retrofilling of the root apex) |
| bone substitute group | Experimental | which will undergo apical surgery plus bone substitute Receives: Other: bone substitute |
| concentrated growth factors group | Experimental | which will undergo apical surgery plus CGF (concentrated growth factors) Receives: Other: concentrated growth factor |
| bone substitute and CGF group | Experimental | which will undergo apical surgery plus bone substitute and CGF gel Receives: Combination Product: concentrated growth factor + bone substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root apex healing status
Measurements of postoperative apical bone healing were obtained using cone-beam computed tomography (CBCT) in horizontal, coronal, and sagittal planes, respectively.
Unit: mm
Measured: up to 12 months
Secondary outcomes (2)
pain status
Record the pain condition of patients postoperatively at 2, 6, and 12 hours, as well as daily for 7 days after the surgery through questionnaire surveys.
The pain scale is as follows:
0: No pain;
- (mild): Discomfort or pain that is felt but does not require medication;
- (moderate): Pain that is uncomfortable but tolerable, and can be effectively relieved with pain medication;
- (severe): Pain that is difficult to bear.
Measured: 7 days
postoperative swelling
Record the postoperative swelling of patients postoperatively at 2, 6, and 12 hours, as well as daily for 7 days after the surgery through questionnaire surveys.
Postoperative swelling score will be rated on the following scale:
0: No swelling;
- Mild swelling at the surgical site;
- Moderate swelling outside the surgical area;
- Severe swelling outside the treatment area.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start15 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concentrated Growth FactorStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Luo, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938907
- Sponsor's protocol ID
- RH2200003294
- Status last verified
- Sep 2023
- First submitted
- 22 Jun 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Concentrated Growth Factors on Healing of Apicomarginal Defects: a Prospective Study
- ClinicalTrials.gov ID
- NCT05938907
- Acronym / sponsor ID
- RH2200003294
- Conditions
- Concentrated Growth Factor, Bone Substitute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Jul 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.
The persistent and chronic apical periodontitis has caused great difficulties for clinical physicians. Ensuring rapid and successful healing of the extensively damaged periapical region is a pressing issue that needs to be addressed. The treatment options include traditional apical surgery, simultaneous placement of bone powder and membrane after apical surgery, and simultaneous placement of sticky bone (bone powder mixed with concentrated growth factors gel) and membrane. However, high-quality evidence regarding these various treatment options is scarce. The purpose of this study is to compare the advantages and disadvantages of each treatment option, in order to guide clinical physicians in the application of apical surgery.
Detailed description
This prospective study will recruit 72 patients with chronic periapical periodontitis in their anterior teeth or premolars, all of which have received comprehensive root canal treatment. The patients will be randomly divided into four groups: Group A, which will undergo only apical surgery (including apicoectomy, inflammation debridement, and retrofilling of the root apex); Group B, which will undergo apical surgery plus bone powder; Group C, which will undergo apical surgery plus CGF (concentrated growth factors); and Group D, which will undergo apical surgery plus bone powder and CGF gel. Each group will consist of 18 patients, and all surgeries will be performed by the same experienced doctor. The participants will receive a 1-year follow-up with the assistance of a professional doctor, including questionnaire data and daily records of pain and swelling at 2, 6, and 12 hours and 7 days after the intervention. Cone-beam computed tomography (CBCT) images will also be taken before the surgery, immediately after the surgery, and at 2, 3, 4, 6, and 12 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| only apical surgery group | No intervention | –which will undergo only apical surgery (including apicoectomy, inflammation debridement, and retrofilling of the root apex) |
| bone substitute group | Experimental | Other: bone substitutewhich will undergo apical surgery plus bone substitute |
| concentrated growth factors group | Experimental | Other: concentrated growth factorwhich will undergo apical surgery plus CGF (concentrated growth factors) |
| bone substitute and CGF group | Experimental | Combination Product: concentrated growth factor + bone substitutewhich will undergo apical surgery plus bone substitute and CGF gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old or above.
- Tooth with significant symptoms or with root apex bone tissue destruction that cannot be treated by non-surgical methods.
- The affected tooth is either an anterior tooth or a premolar.
- The size of the lesion during preoperative cone beam computed tomography (CBCT) coronal acquisition is at least 6 mm but not more than 12 mm.
- The affected tooth has undergone successful root canal treatment.
Key exclusion criteria (5 listed)
- Severe periodontal destruction, with over 1/3 of the root length absorbed by alveolar bone.
- CBCT shows root fracture or root canal perforation.
- After root apex surgery, crown-root ratio ≤1:1.
- Presence of surgical contraindications, systemic and local factors that affect wound healing.
- Pregnant women and females planning to conceive within the next two years.
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 |
|---|---|---|
| concentrated growth factorImplanting concentrated growth factor into the area of root apical bone defect | Other | concentrated growth factors group |
| bone substituteImplanting bone substitute into the area of root apical bone defect | Other | bone substitute group |
| concentrated growth factor + bone substituteImplanting concentrated growth factor + bone substitute into the area of root apical bone defect | Combination product | bone substitute and CGF group |
Primary outcome
Root apex healing status
Time frame: up to 12 months
Measurements of postoperative apical bone healing were obtained using cone-beam computed tomography (CBCT) in horizontal, coronal, and sagittal planes, respectively. Unit: mm
2 secondary outcomes
pain status
Time frame: 7 days
postoperative swelling
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing concentrated growth factor, bone substitute and concentrated growth factor + bone substitute in people with Concentrated Growth Factor and Bone Substitute, run by West China Hospital 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Luo (15103660395, luowen228@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root apex healing status (time frame: up to 12 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 21 Sep 2023.