Application of Concentrated Growth Factors in Alveolar Ridge Preservation

Alveolar Ridge Preservation Clinical Trial

Official title:

Study on the Effect of Concentrated Growth Factor in Promoting the Regeneration and Preservation of Soft and Hard Tissues

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308536
• Other study ID #: KY-2023-045
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: Genying Zhuang, Master
• Phone: 13758195143
• Email: 20918620[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the role of CGF in the regeneration or preservation of soft and hard tissues during tooth extraction site preservation surgery.

Description:

A prospective, randomized controlled trial is designed to explore the role of CGF in the regeneration or preservation of soft and hard tissues in extraction site preservation. Using random number table, 20 patients were randomly divided into 4 groups using different filling materials in the extraction socket and materials for the wound sealing. Group A (5cases): bone powder + collagen membrane; Group B (5 cases): bone powder + collagen membrane + CGF membrane; Group C (5 cases): bone powder mixed CGF gel + collagen membrane + CGF membrane; Group D (5 cases): bone powder + CGF membrane.

Extraction and site preservation surgery were performed by the same physician and clinical follow-up was more than 6 months after surgery. The four groups will be compared on several variables, including the changes in pain score, Landry wound healing index, membrane exposure area, keratinized gingival width, buccolingual gingival width, alveolar crest width and height.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

Voluntarily participate in this trial and sign a written informed consent; Patients aged 25 = age = 45 years; The combination of intraoral and imaging examinations confirms that the affected tooth has no preservation value, requires tooth extraction, and the patient is willing to use site preservation; No progressive periodontal disease or acute apical periodontitis in the affected teeth; No long-term history of oral bisphosphonates; Non smoking patients; No systemic diseases such as diabetes and hypertension.

Exclusion Criteria:

Patients who have difficulty tolerating surgery; Patients under 25 years old or above 45 years old; The whole body is accompanied by hypertension, diabetes and other serious systemic diseases, which need to be controlled by drugs; Patients who take oral medication that affects bone metabolism for at least one month due to the need for disease treatment; Patients who take medication that may affect platelet function was used within 3 months due to the need for disease treatment; Patients unable to undergo X-ray imaging examination due to pregnancy or preparation after site preservation surgery; Patients who Smoke; The apical and periodontal inflammation is in the acute phase (purulent phase) Regular follow-up or follow-up for more than 6 months is not allowed

Related Conditions & MeSH terms

• Alveolar Ridge Preservation

Intervention

Procedure:
• bone powder + collagen membrane
Fill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen membrane.
• bone powder + collagen membrane + CGF membrane
Fill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen membrane plus CGF membrane(CGF gel is pressed into a film)
• bone powder mixed wih CGF gel + collagen membrane + CGF membrane
Fill the extraction socket with Bio-Oss® bone powder mixed with CGF gel (CGF gel is cutted into granules ), and cover the extraction wound with Bio-Gide® collagen membrane plus CGF membrane(CGF gel is pressed into a film)
• bone powder + CGF membrane
Fill the extraction socket with Bio-Oss® bone powder and cover the extraction wound with CGF membrane(CGF gel is pressed into a film)

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital Zhejiang University School of Medicine	Yiwu	Zhejiang Procince

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

Li S, Yang H, Duan Q, Bao H, Li A, Li W, Chen J, He Y. A comparative study of the effects of platelet-rich fibrin, concentrated growth factor and platelet-poor plasma on the healing of tooth extraction sockets in rabbits. BMC Oral Health. 2022 Mar 23;22(1 — View Citation

Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the width of keratinized gingiva	the width of keratinized gingiva measured by periodontal probe	preoperative, 3 months and 6 months after surgery
Primary	the horizontal width (from buccal to lingual at the alveolar top ) of gingiva	the horizontal width of gingiva measured by periodontal probe	immediate , 3 months and 6 months postoperative
Primary	the horizontal bone resorption of alveolar crest	Compared with immediate postoperative, the horizontal width of alveolar crest decreased at 3months and 6 months, postoperative alveolar bone resorption progressed with time	immediate , 3 months and 6 months postoperative
Primary	the vertical bone resorption of alveolar crest	the vertical width of alveolar crest decreased at 3months and 6 months postoperative compared with the immediate postoperative	immediate , 3 months and 6 months postoperative
Primary	the average gray value of alveolar bone	the average gray value of alveolar bone	immediate , 3 months and 6 months postoperative
Secondary	Landry wound healing index	scores:1,2,3,4,5 according to the gingival healing status	7 days and 12 days after surgery
Secondary	reduction in membrane exposure area	membrane exposure area reduce different in four groups	7 days,12 days and one month after surgery
Secondary	pain score	scores: 2,4,6,8,10 using the Wong-Baker facial pain scale revision (FPS-R)	1day, 3days after surgerys