Using concentrated growth factors to improve healing in dental surgery
Effect of Concentrated Growth Factors on Healing of Apicomarginal Defects: a Prospective Study
NA · West China Hospital · NCT05938907
This study is testing if using concentrated growth factors can help people with chronic tooth infections heal better after dental surgery compared to other treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West China Hospital (other) |
| Locations | 1 site (Haikou, Hainan) |
| Trial ID | NCT05938907 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate the effectiveness of concentrated growth factors (CGF) in promoting healing of apicomarginal defects in patients with chronic periapical periodontitis. A total of 72 patients will be randomly assigned to four treatment groups: apical surgery alone, apical surgery with bone powder, apical surgery with CGF, and apical surgery with both bone powder and CGF. Each patient will be monitored for one year post-surgery, with assessments including pain and swelling records, as well as cone-beam computed tomography (CBCT) imaging at multiple time points to evaluate healing progress. The study seeks to provide high-quality evidence to guide clinical decisions in apical surgery treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant symptoms and bone tissue destruction in anterior teeth or premolars that cannot be treated non-surgically.
Not a fit: Patients with severe periodontal destruction, root fractures, or other surgical contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing outcomes for patients undergoing apical surgery for chronic periapical periodontitis.
How similar studies have performed: While there is limited high-quality evidence on the use of CGF in this context, similar studies have shown promising results in other applications of growth factors in dental surgery.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Haikou, Hainan
- First Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (RECRUITING)
Study contacts
- Study coordinator: Wen Luo
- Email: luowen228@163.com
- Phone: 15103660395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Concentrated Growth Factor, Bone Substitute