Application of Concentrated Growth Factors in Alveolar Ridge Preservation

NCT ID: NCT06308536

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-09

Study Completion Date

2025-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Alveolar Ridge Preservation Concentrated Growth Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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bone powder + collagen membrane

Fill the extraction socket with bone powder, and cover the extraction wound with collagen membrane.

Group Type ACTIVE_COMPARATOR

bone powder + collagen membrane

Intervention Type PROCEDURE

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 bone powder, and cover the extraction wound with collagen membrane and CGF membrane.

Group Type EXPERIMENTAL

bone powder + collagen membrane + CGF membrane

Intervention Type PROCEDURE

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 bone powder mixed with CGF gel, and cover the extraction wound with collagen membrane and CGF membrane.

Group Type EXPERIMENTAL

bone powder mixed wih CGF gel + collagen membrane + CGF membrane

Intervention Type PROCEDURE

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 bone powder, and cover the extraction wound with CGF membrane.

Group Type EXPERIMENTAL

bone powder + CGF membrane

Intervention Type PROCEDURE

Fill the extraction socket with Bio-Oss® bone powder and cover the extraction wound with CGF membrane(CGF gel is pressed into a film)

Interventions

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bone powder + collagen membrane

Fill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen membrane.

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Genying Zhuang, Master

Role: STUDY_DIRECTOR

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Locations

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The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang Procince, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Genying Zhuang, Master

Role: CONTACT

13758195143

Facility Contacts

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Genying Zhuang, Master

Role: primary

13758195143

References

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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.

Reference Type RESULT
PMID: 35321697 (View on PubMed)

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.

Reference Type RESULT
PMID: 22211303 (View on PubMed)

Other Identifiers

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KY-2023-045

Identifier Type: -

Identifier Source: org_study_id

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