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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bone powder + collagen membrane | Active Comparator | Fill the extraction socket with bone powder, and cover the extraction wound with 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. |
|
| 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. |
|
| bone powder + CGF membrane | Experimental | Fill the extraction socket with bone powder, and cover the extraction wound with CGF membrane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bone powder + collagen membrane | Procedure | Fill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen membrane. |
|
| 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 |
| 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 |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Genying Zhuang, Master | Contact | 13758195143 | 20918620@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Genying Zhuang, Master | The Fourth Affiliated Hospital Zhejiang University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Yiwu | Zhejiang Procince | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35321697 | Result | 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. | |
| 22211303 | Result |
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| bone powder + collagen membrane + CGF membrane | 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 | 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 | 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) |
|
| 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 |
| 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. |