Bone Substitute, Concentrated Growth Factor
Conditions
Brief 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. 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.
Interventions
Implanting concentrated growth factor into the area of root apical bone defect
OTHERbone substitute
Implanting bone substitute into the area of root apical bone defect
COMBINATION_PRODUCTconcentrated growth factor + bone substitute
Implanting concentrated growth factor + bone substitute into the area of root apical bone defect
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Root apex healing status | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain status | 7 days | 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; 1. (mild): Discomfort or pain that is felt but does not require medication; 2. (moderate): Pain that is uncomfortable but tolerable, and can be effectively relieved with pain medication; 3. (severe): Pain that is difficult to bear. |
| postoperative swelling | 7 days | 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; 1. Mild swelling at the surgical site; 2. Moderate swelling outside the surgical area; 3. Severe swelling outside the treatment area. |
Countries
China
Contacts
Primary ContactWen Luo
Backup ContactKaiyue Zheng
Outcome results
None listed