Alveolar Ridge Preservation, Concentrated Growth Factor
Conditions
Keywords
extraction site preservation, concentrated growth factor, CGF, soft and hard tissue regeneration
Brief summary
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.
Interventions
PROCEDUREbone powder + collagen membrane
Fill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen membrane.
PROCEDUREbone 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)
PROCEDUREbone 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)
PROCEDUREbone 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)
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the width of keratinized gingiva | 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 | immediate , 3 months and 6 months postoperative | the horizontal width of gingiva measured by periodontal probe |
| the horizontal bone resorption of alveolar crest | 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 | 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 | immediate , 3 months and 6 months postoperative | the average gray value of alveolar bone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Landry wound healing index | 7 days and 12 days after surgery | scores:1,2,3,4,5 according to the gingival healing status |
| reduction in membrane exposure area | 7 days,12 days and one month after surgery | membrane exposure area reduce different in four groups |
| pain score | 1day, 3days after surgerys | scores: 2,4,6,8,10 using the Wong-Baker facial pain scale revision (FPS-R) |
Countries
China
Contacts
Primary ContactGenying Zhuang, Master
Outcome results
None listed