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

Last updated: September 19, 2023
Sponsor: West China Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

concentrated growth factor + bone substitute

concentrated growth factor

bone substitute

Clinical Study ID

NCT05938907
RH2200003294
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years old or above.
  • Tooth with significant symptoms or with root apex bone tissue destruction that cannotbe 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 buccalalveolar bone defect present.
  • Good oral hygiene and compliance with medical instructions.

Exclusion

Exclusion Criteria:

  • Severe periodontal destruction, with over 1/3 of the root length absorbed by alveolarbone.
  • 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 woundhealing.
  • Pregnant women and females planning to conceive within the next two years.

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: concentrated growth factor + bone substitute
Phase:
Study Start date:
June 15, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan 570102
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.