NCT05938907

Effect of Concentrated Growth Factors on Healing of Apicomarginal Defects: a Prospective Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Concentrated Growth Factor
• Bone Substitute

Interventions

Type	Name	Description
OTHER	concentrated growth factor	Implanting concentrated growth factor into the area of root apical bone defect
OTHER	bone substitute	Implanting bone substitute into the area of root apical bone defect
COMBINATION_PRODUCT	concentrated growth factor + bone substitute	Implanting concentrated growth factor + bone substitute into the area of root apical bone defect

Timeline

• Start date: 2023-06-15
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-07-11
• Last updated: 2023-09-21

Locations

1 site across 1 country: China