{"title":"使用重组人成纤维细胞生长因子（rhFGF）-2 与碳酸盐磷灰石颗粒或单独使用 rhFGF-2 进行牙周再生治疗：为期 12 个月的随机对照试验。","authors":"Kentaro Imamura, Wataru Yoshida, Fumi Seshima, Hideto Aoki, Keiko Yamashita, Yurie Kitamura, Tasuku Murakami, Mayuri Ambiru, Takahiro Bizenjima, Akihiko Katayama, Sachiyo Tomita, Atsushi Saito","doi":"10.1007/s00784-024-05979-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>This randomized controlled trial compared the outcomes of recombinant human fibroblast growth factor (rhFGF)-2 plus carbonate apatite (CO<sub>3</sub>Ap) granules with rhFGF-2 alone in the treatment of intrabony periodontal defects.</p><p><strong>Materials and methods: </strong>Patients with Stage III Grade B/C periodontitis who had completed initial periodontal therapy and had intrabony defects with a depth of ≥ 3 mm were included. Defects were treated solely with rhFGF-2 (control) or rhFGF-2 plus CO<sub>3</sub>Ap (test). Periodontal parameters and a patient-reported outcome measure (PROM) were assessed at baseline, at 6, 9 and 12 months postoperatively. The primary outcome was the change in clinical attachment level (CAL) from baseline to 12 months postoperatively. Using the Friedman test with Dunn's post-test, intragroup data were compared over time, and Mann-Whitney U test was used to assess intergroup data at each time point.</p><p><strong>Results: </strong>Forty-eight sites in 38 patients were subjected to analysis. At 12 months postoperatively, CAL in both groups showed a significant improvement from baseline (p < 0.001). CAL gain was 3.4 ± 1.3 mm in the test group and 3.2 ± 1.2 mm in the control group, with no significant intergroup difference (p = 0.567). Radiographic bone fill in the test group (67.2%) was significantly greater than in the control group (32.4%) (p < 0.001). PROM scores showed no difference between groups.</p><p><strong>Conclusions: </strong>At 12 months, the outcomes including CAL gain and PROM showed no significant differences between groups, although the combination treatment enhanced radiographic bone fill.</p><p><strong>Clinical relevance: </strong>The use of rhFGF-2 (with/without CO<sub>3</sub>Ap) could lead to significant improvement in clinical parameters in the treatment of intrabony periodontal defects. The benefit of adding CO<sub>3</sub>Ap to rhFGF-2 therapy needs further evaluation.</p><p><strong>Clinical trial registration number: </strong>The University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) : UMIN000040783.</p>","PeriodicalId":10461,"journal":{"name":"Clinical Oral Investigations","volume":"28 11","pages":"574"},"PeriodicalIF":3.1000,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Periodontal regenerative therapy using recombinant human fibroblast growth factor (rhFGF)-2 in combination with carbonate apatite granules or rhFGF-2 alone: 12-month randomized controlled trial.\",\"authors\":\"Kentaro Imamura, Wataru Yoshida, Fumi Seshima, Hideto Aoki, Keiko Yamashita, Yurie Kitamura, Tasuku Murakami, Mayuri Ambiru, Takahiro Bizenjima, Akihiko Katayama, Sachiyo Tomita, Atsushi Saito\",\"doi\":\"10.1007/s00784-024-05979-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>This randomized controlled trial compared the outcomes of recombinant human fibroblast growth factor (rhFGF)-2 plus carbonate apatite (CO<sub>3</sub>Ap) granules with rhFGF-2 alone in the treatment of intrabony periodontal defects.</p><p><strong>Materials and methods: </strong>Patients with Stage III Grade B/C periodontitis who had completed initial periodontal therapy and had intrabony defects with a depth of ≥ 3 mm were included. Defects were treated solely with rhFGF-2 (control) or rhFGF-2 plus CO<sub>3</sub>Ap (test). Periodontal parameters and a patient-reported outcome measure (PROM) were assessed at baseline, at 6, 9 and 12 months postoperatively. The primary outcome was the change in clinical attachment level (CAL) from baseline to 12 months postoperatively. Using the Friedman test with Dunn's post-test, intragroup data were compared over time, and Mann-Whitney U test was used to assess intergroup data at each time point.</p><p><strong>Results: </strong>Forty-eight sites in 38 patients were subjected to analysis. At 12 months postoperatively, CAL in both groups showed a significant improvement from baseline (p < 0.001). CAL gain was 3.4 ± 1.3 mm in the test group and 3.2 ± 1.2 mm in the control group, with no significant intergroup difference (p = 0.567). Radiographic bone fill in the test group (67.2%) was significantly greater than in the control group (32.4%) (p < 0.001). PROM scores showed no difference between groups.</p><p><strong>Conclusions: </strong>At 12 months, the outcomes including CAL gain and PROM showed no significant differences between groups, although the combination treatment enhanced radiographic bone fill.</p><p><strong>Clinical relevance: </strong>The use of rhFGF-2 (with/without CO<sub>3</sub>Ap) could lead to significant improvement in clinical parameters in the treatment of intrabony periodontal defects. The benefit of adding CO<sub>3</sub>Ap to rhFGF-2 therapy needs further evaluation.</p><p><strong>Clinical trial registration number: </strong>The University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) : UMIN000040783.</p>\",\"PeriodicalId\":10461,\"journal\":{\"name\":\"Clinical Oral Investigations\",\"volume\":\"28 11\",\"pages\":\"574\"},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2024-10-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Oral Investigations\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00784-024-05979-7\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DENTISTRY, ORAL SURGERY & MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Oral Investigations","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00784-024-05979-7","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DENTISTRY, ORAL SURGERY & MEDICINE","Score":null,"Total":0}
引用次数: 0
摘要
研究目的这项随机对照试验比较了重组人成纤维细胞生长因子（rhFGF）-2加碳酸盐磷灰石（CO3Ap）颗粒与单独使用rhFGF-2治疗骨内牙周缺损的效果：纳入已完成初始牙周治疗且骨内缺损深度≥ 3 mm 的 III 期 B/C 级牙周炎患者。缺损处只接受 rhFGF-2（对照组）或 rhFGF-2 加 CO3Ap（试验组）治疗。在基线、术后 6 个月、9 个月和 12 个月对牙周参数和患者报告的结果测量（PROM）进行评估。主要结果是临床附着水平（CAL）从基线到术后 12 个月的变化。采用弗里德曼检验和邓恩后检验比较组内随时间变化的数据，采用曼-惠特尼U检验评估各时间点的组间数据：对 38 名患者的 48 个部位进行了分析。术后 12 个月时，两组患者的 CAL 与基线相比均有显著改善（p 结论：术后 12 个月时，两组患者的 CAL 与基线相比均有显著改善：12个月时，虽然联合治疗增强了放射学骨填充，但包括CAL增量和PROM在内的结果显示组间无显著差异：临床意义：使用 rhFGF-2（含/不含 CO3Ap）治疗骨内牙周缺损可显著改善临床参数。在rhFGF-2疗法中添加CO3Ap的益处需要进一步评估：大学医院医学信息网-临床试验注册中心（UMIN-CTR）：UMIN000040783。
Periodontal regenerative therapy using recombinant human fibroblast growth factor (rhFGF)-2 in combination with carbonate apatite granules or rhFGF-2 alone: 12-month randomized controlled trial.
Objectives: This randomized controlled trial compared the outcomes of recombinant human fibroblast growth factor (rhFGF)-2 plus carbonate apatite (CO3Ap) granules with rhFGF-2 alone in the treatment of intrabony periodontal defects.
Materials and methods: Patients with Stage III Grade B/C periodontitis who had completed initial periodontal therapy and had intrabony defects with a depth of ≥ 3 mm were included. Defects were treated solely with rhFGF-2 (control) or rhFGF-2 plus CO3Ap (test). Periodontal parameters and a patient-reported outcome measure (PROM) were assessed at baseline, at 6, 9 and 12 months postoperatively. The primary outcome was the change in clinical attachment level (CAL) from baseline to 12 months postoperatively. Using the Friedman test with Dunn's post-test, intragroup data were compared over time, and Mann-Whitney U test was used to assess intergroup data at each time point.
Results: Forty-eight sites in 38 patients were subjected to analysis. At 12 months postoperatively, CAL in both groups showed a significant improvement from baseline (p < 0.001). CAL gain was 3.4 ± 1.3 mm in the test group and 3.2 ± 1.2 mm in the control group, with no significant intergroup difference (p = 0.567). Radiographic bone fill in the test group (67.2%) was significantly greater than in the control group (32.4%) (p < 0.001). PROM scores showed no difference between groups.
Conclusions: At 12 months, the outcomes including CAL gain and PROM showed no significant differences between groups, although the combination treatment enhanced radiographic bone fill.
Clinical relevance: The use of rhFGF-2 (with/without CO3Ap) could lead to significant improvement in clinical parameters in the treatment of intrabony periodontal defects. The benefit of adding CO3Ap to rhFGF-2 therapy needs further evaluation.
Clinical trial registration number: The University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) : UMIN000040783.
期刊介绍：
The journal Clinical Oral Investigations is a multidisciplinary, international forum for publication of research from all fields of oral medicine. The journal publishes original scientific articles and invited reviews which provide up-to-date results of basic and clinical studies in oral and maxillofacial science and medicine. The aim is to clarify the relevance of new results to modern practice, for an international readership. Coverage includes maxillofacial and oral surgery, prosthetics and restorative dentistry, operative dentistry, endodontics, periodontology, orthodontics, dental materials science, clinical trials, epidemiology, pedodontics, oral implant, preventive dentistiry, oral pathology, oral basic sciences and more.
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