An interventional study of bone powder + collagen membrane and bone powder + collagen membrane + CGF membrane in Alveolar Ridge Preservation and Concentrated Growth Factor, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Treatment
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.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 90 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Fill the extraction socket with bone powder, and cover the extraction wound with collagen membrane.
Procedure: bone powder + collagen membrane
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
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
Fill the extraction socket with bone powder, and cover the extraction wound with CGF membrane.
Procedure: bone powder + CGF membrane
Fill the extraction socket with Bio-Oss® bone powder, and cover the extraction wound with Bio-Gide® collagen 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)
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)
Fill the extraction socket with Bio-Oss® bone powder and cover the extraction wound with CGF membrane(CGF gel is pressed into a film)
the width of keratinized gingiva
the width of keratinized gingiva measured by periodontal probe
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: immediate , 3 months and 6 months postoperative
the average gray value of alveolar bone
the average gray value of alveolar bone
Time frame: immediate , 3 months and 6 months postoperative
Landry wound healing index
scores:1,2,3,4,5 according to the gingival healing status
Time frame: 7 days and 12 days after surgery
reduction in membrane exposure area
membrane exposure area reduce different in four groups
Time frame: 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)
Time frame: 1day, 3days after surgerys
Plan to share: No
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine