NCT06308536

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 7, 2024

Last Update Submit

March 7, 2024

Conditions

Alveolar Ridge PreservationConcentrated Growth Factor

Keywords

extraction site preservationconcentrated growth factorCGFsoft and hard tissue regeneration

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Landry wound healing index

    7 days and 12 days after surgery

  • reduction in membrane exposure area

    7 days,12 days and one month after surgery

  • pain score

    1day, 3days after surgerys

Study Arms (4)

bone powder + collagen membrane

ACTIVE COMPARATOR

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

Procedure: bone powder + collagen membrane

bone powder + collagen membrane + CGF membrane

EXPERIMENTAL

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

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

EXPERIMENTAL

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

bone powder + CGF membrane

EXPERIMENTAL

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

Procedure: bone powder + CGF membrane

Interventions

bone powder + collagen membranePROCEDURE

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

bone powder + collagen membrane
bone powder + collagen membrane + CGF membranePROCEDURE

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

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

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

bone powder + CGF membrane

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang Procince, 310000, China

RECRUITING

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

    PMID: 35321697RESULT

  • 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.

    PMID: 22211303RESULT

Study Officials

  • Genying Zhuang, Master

    The Fourth Affiliated Hospital Zhejiang University School of Medicine

    STUDY DIRECTOR

Central Study Contacts

Genying Zhuang, Master

CONTACT

1375819514320918620@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 13, 2024

Study Start

May 9, 2023

Primary Completion

October 1, 2024

Study Completion

April 1, 2025

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)