Clinical trial

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

Name
RH2200003294
Description
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.
Trial arms
Trial start
2023-06-15
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Treatment
concentrated growth factor
Implanting concentrated growth factor into the area of root apical bone defect
Arms:
concentrated growth factors group
bone substitute
Implanting bone substitute into the area of root apical bone defect
Arms:
bone substitute group
concentrated growth factor + bone substitute
Implanting concentrated growth factor + bone substitute into the area of root apical bone defect
Arms:
bone substitute and CGF group
Size
72
Primary endpoint
Root apex healing status
up to 12 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}
Updated at
2023-09-21

1 organization

1 product

2 indications

Indication
Bone Substitute