Alveolar Ridge PreservationNCT06308536
Application of Concentrated Growth Factors in Alveolar Ridge Preservation
A study testing bone powder + collagen membrane, bone powder + collagen membrane + CGF membrane and bone powder mixed wih CGF gel + collagen membrane + CGF membrane in people with Alveolar Ridge Preservation and Concentrated Growth Factor, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
To explore the role of CGF in the regeneration or preservation of soft and hard tissues during tooth extraction site preservation surgery. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Alveolar Ridge Preservation, Concentrated Growth Factor
- What is being tested?
- bone powder + collagen membrane, bone powder + collagen membrane + CGF membrane and bone powder mixed wih CGF gel + collagen membrane + CGF membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang Procince, 310000
Genying Zhuang, Master, 13758195143, 20918620@zju.edu.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- bone powder + collagen membrane, bone powder + collagen membrane + CGF membrane, bone powder mixed wih CGF gel + collagen membrane + CGF membrane, bone powder + CGF membrane
- Keywords
- extraction site preservation, concentrated growth factor, CGF, soft and hard tissue regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone powder + collagen membraneProcedure or surgery
Fill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen membrane.
bone powder + collagen membrane + CGF membraneProcedure or surgery
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 membraneProcedure or surgery
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 membraneProcedure or surgery
Fill the extraction socket with Bio-Oss® bone powder and cover the extraction wound with CGF membrane(CGF gel is pressed into a film)
| Study group | Role | What they receive |
|---|---|---|
| bone powder + collagen membrane | Active comparator | Fill the extraction socket with bone powder, and cover the extraction wound with collagen membrane. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: bone powder + CGF membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
the width of keratinized gingiva
the width of keratinized gingiva measured by periodontal probe
Measured: 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
Measured: 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
Measured: 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
Measured: immediate , 3 months and 6 months postoperative
the average gray value of alveolar bone
the average gray value of alveolar bone
Measured: immediate , 3 months and 6 months postoperative
Secondary outcomes (3)
Landry wound healing index
scores:1,2,3,4,5 according to the gingival healing status
Measured: 7 days and 12 days after surgery
reduction in membrane exposure area
membrane exposure area reduce different in four groups
Measured: 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)
Measured: 1day, 3days after surgerys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start9 May 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Genying Zhuang, Master, Study director, The Fourth Affiliated Hospital Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308536
- Sponsor's protocol ID
- KY-2023-045
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35321697Tan 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.
PubMed 22211303
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Concentrated Growth Factor in Promoting the Regeneration and Preservation of Soft and Hard Tissues
- ClinicalTrials.gov ID
- NCT06308536
- Acronym / sponsor ID
- KY-2023-045
- Keywords
- extraction site preservation, concentrated growth factor, CGF, soft and hard tissue regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the role of CGF in the regeneration or preservation of soft and hard tissues during tooth extraction site preservation surgery.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bone powder + collagen membrane | Active comparator | Procedure: bone powder + collagen membraneFill the extraction socket with bone powder, and cover the extraction wound with collagen membrane. |
| bone powder + collagen membrane + CGF membrane | Experimental | Procedure: bone powder + collagen membrane + CGF membraneFill the extraction socket with bone powder, and cover the extraction wound with collagen membrane and CGF membrane. |
| bone powder mixed wih CGF gel + collagen membrane + CGF membrane | Experimental | Procedure: bone powder mixed wih CGF gel + collagen membrane + CGF membraneFill the extraction socket with bone powder mixed with CGF gel, and cover the extraction wound with collagen membrane and CGF membrane. |
| bone powder + CGF membrane | Experimental | Procedure: bone powder + CGF membraneFill the extraction socket with bone powder, and cover the extraction wound with CGF membrane. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone powder + collagen membraneFill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen membrane. | Procedure or surgery | bone powder + collagen membrane |
| bone powder + collagen membrane + CGF membraneFill 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) | Procedure or surgery | bone powder + collagen membrane + CGF membrane |
| bone powder mixed wih CGF gel + collagen membrane + CGF membraneFill 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) | Procedure or surgery | bone powder mixed wih CGF gel + collagen membrane + CGF membrane |
| bone powder + CGF membraneFill the extraction socket with Bio-Oss® bone powder and cover the extraction wound with CGF membrane(CGF gel is pressed into a film) | Procedure or surgery | bone powder + CGF membrane |
Primary outcome
the width of keratinized gingiva
Time frame: preoperative, 3 months and 6 months after surgery
the width of keratinized gingiva measured by periodontal probe
the horizontal width (from buccal to lingual at the alveolar top ) of gingiva
Time frame: immediate , 3 months and 6 months postoperative
the horizontal width of gingiva measured by periodontal probe
the horizontal bone resorption of alveolar crest
Time frame: immediate , 3 months and 6 months postoperative
Compared with immediate postoperative, the horizontal width of alveolar crest decreased at 3months and 6 months, postoperative alveolar bone resorption progressed with time
the vertical bone resorption of alveolar crest
Time frame: immediate , 3 months and 6 months postoperative
the vertical width of alveolar crest decreased at 3months and 6 months postoperative compared with the immediate postoperative
the average gray value of alveolar bone
Time frame: immediate , 3 months and 6 months postoperative
the average gray value of alveolar bone
3 secondary outcomes
Landry wound healing index
Time frame: 7 days and 12 days after surgery
reduction in membrane exposure area
Time frame: 7 days,12 days and one month after surgery
pain score
Time frame: 1day, 3days after surgerys
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Results publication: PubMed 35321697Li 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.
- Results publication: PubMed 22211303Tan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genying Zhuang, Master study director
The Fourth Affiliated Hospital Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone powder + collagen membrane, bone powder + collagen membrane + CGF membrane and bone powder mixed wih CGF gel + collagen membrane + CGF membrane in people with Alveolar Ridge Preservation and Concentrated Growth Factor, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Genying Zhuang, Master (13758195143, 20918620@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the width of keratinized gingiva (time frame: preoperative, 3 months and 6 months after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06308536, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.