Application of Concentrated Growth Factors in Alveolar Ridge Preservation

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

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

Study Overview

• Status: Recruiting
• Conditions: Alveolar Ridge Preservation; Concentrated Growth Factor
• Intervention / Treatment: Procedure: bone powder + collagen membrane; Procedure: bone powder + collagen membrane + CGF membrane; Procedure: bone powder mixed wih CGF gel + collagen membrane + CGF membrane; Procedure: bone powder + CGF membrane

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Genying Zhuang, Master; Phone Number: 13758195143; Email: 20918620@zju.edu.cn

Study Locations

• China
  • Zhejiang Procince
    • Yiwu, Zhejiang Procince, China, 310000
      • Recruiting
      • The Fourth Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Genying Zhuang, Master; Phone Number: 13758195143; Email: 20918620@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bone powder + collagen membrane; Fill the extraction socket with bone powder, and cover the extraction wound with collagen membrane.	Procedure: bone powder + collagen membrane; Fill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen membrane.
Experimental: bone powder + collagen membrane + CGF membrane; Fill the extraction socket with bone powder, and cover the extraction wound with collagen membrane and CGF membrane.	Procedure: 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)
Experimental: bone powder mixed wih CGF gel + collagen membrane + CGF membrane; Fill the extraction socket with bone powder mixed with CGF gel, and cover the extraction wound with collagen membrane and CGF membrane.	Procedure: 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)
Experimental: bone powder + CGF membrane; Fill the extraction socket with bone powder, and cover the extraction wound with CGF membrane.	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the width of keratinized gingiva	the width of keratinized gingiva measured by periodontal probe	preoperative, 3 months and 6 months after surgery
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
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
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
the average gray value of alveolar bone	the average gray value of alveolar bone	immediate , 3 months and 6 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Landry wound healing index	scores:1,2,3,4,5 according to the gingival healing status	7 days and 12 days after surgery
reduction in membrane exposure area	membrane exposure area reduce different in four groups	7 days,12 days and one month after surgery
pain score	scores: 2,4,6,8,10 using the Wong-Baker facial pain scale revision (FPS-R)	1day, 3days after surgerys

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Study Director: Genying Zhuang, Master, The Fourth Affiliated Hospital Zhejiang University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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):87. doi: 10.1186/s12903-022-02126-0.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: CGF; concentrated growth factor; extraction site preservation; soft and hard tissue regeneration
• Other Study ID Numbers: KY-2023-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No