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

NCT05938907 | Unknown

• 1 other identifier: RH2200003294
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Concentrated Growth Factor; Bone Substitute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pain status

  7 days

• postoperative swelling

  7 days

Study Arms (4)

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

Other: bone substitute

concentrated growth factors group

EXPERIMENTAL

which will undergo apical surgery plus CGF (concentrated growth factors)

Other: concentrated growth factor

bone substitute and CGF group

EXPERIMENTAL

which will undergo apical surgery plus bone substitute and CGF gel

Combination Product: concentrated growth factor + bone substitute

Interventions

concentrated growth factor OTHER

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

concentrated growth factors group

bone substitute OTHER

Implanting bone substitute into the area of root apical bone defect

bone substitute group

concentrated growth factor + bone substitute COMBINATION_PRODUCT

Implanting concentrated growth factor + bone substitute into the area of root apical bone defect

bone substitute and CGF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570102, China

RECRUITING

MeSH Terms

Interventions

Bone Substitutes

Intervention Hierarchy (Ancestors)

Biocompatible Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Wen Luo

CONTACT

15103660395; luowen228@163.com

Kaiyue Zheng

CONTACT

18976528173; 1032638813@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 11, 2023
• Study Start: June 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)