Study on the Effect of Concentrated Growth Factor in Promoting the Regeneration and Preservation of Soft and Hard Tissues
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- the width of keratinized gingiva
研究概览
简要总结
To explore the role of CGF in the regeneration or preservation of soft and hard tissues during tooth extraction site preservation surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
bone powder + collagen membrane
Fill the extraction socket with bone powder, and cover the extraction wound with collagen membrane.
干预措施: bone powder + collagen membrane (Procedure)
bone powder + collagen membrane + CGF membrane
Fill the extraction socket with bone powder, and cover the extraction wound with collagen membrane and CGF membrane.
干预措施: bone powder + collagen membrane + CGF membrane (Procedure)
bone powder mixed wih CGF gel + 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.
干预措施: bone powder mixed wih CGF gel + collagen membrane + CGF membrane (Procedure)
bone powder + CGF membrane
Fill the extraction socket with bone powder, and cover the extraction wound with CGF membrane.
干预措施: bone powder + CGF membrane (Procedure)
结局指标
主要结局
the width of keratinized gingiva
时间窗: 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
时间窗: immediate , 3 months and 6 months postoperative
the horizontal width of gingiva measured by periodontal probe
the horizontal bone resorption of alveolar crest
时间窗: 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 average gray value of alveolar bone
时间窗: immediate , 3 months and 6 months postoperative
the average gray value of alveolar bone
the vertical bone resorption of alveolar crest
时间窗: 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
次要结局
- 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)