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

Bone Substitute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938907
• Other study ID #: RH2200003294
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: West China Hospital
• Contact: Wen Luo
• Phone: 15103660395
• Email: luowen228[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Substitute

Intervention

Other:
• concentrated growth factor
Implanting concentrated growth factor into the area of root apical bone defect
• 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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Hainan Medical University	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 12 months
Secondary	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.	7 days
Secondary	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.	7 days