Effects of Ribose Cross-Linked Thick Collagen Membranes and Connective Tissue Grafts on Peri-Implant Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peri-implant Mucosa Thickness
研究概览
简要总结
Background:This study aimed to compare the effect of ribose cross-linked thick collagen membrane (RCCM) with that of subepithelial connective tissue graft (CTG) in sites with soft tissue deficiency in the horizontal aspect around the implant.
Methods:Single implant sites were included in the study of 20 systemically healthy patients. All procedures were performed concurrently with implant placement; SCTG was administered in ten patients, and RCCM in the other ten. Before the operation, the PIMT and peri-implant mucosa width (PIMW) were measured. Visual analog scale (VAS) and Oral Health Impact profile-14 (OHIP-14) scores were recorded on post-operative days 1, 3, and 7. At 1 and 3 months measurements were repeated.
Results:In terms of PIMT, an average increase of 1.87 mm was recorded in the RCCM group and 1.99 mm in the SCTG group. The rate of increase in PIMT was statistically similar in both the groups (p>0.05). The OHIP-14 and VAS scores were similar between the groups on days 1, 3, and 7. There was a decrease at 3 months in both the groups.
Conclusion:Within the limits of this study, RCCM provided a similar increase in PIMT as SCTG. RCCM is a promising alternative to SCTG for increasing the PIMT.
Keywords: Collagen, Connective tissue, Dental implants, Oral mucosa
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy
- •The edentulous space for which implant treatment is planned to be single tooth size and molar tooth site
- •Those with soft tissue deficiency in the horizontal aspect in the site where implant treatment is planned
- •Age between 18-60 years
- •Does not have a condition that may cause a bleeding disorder
- •No nausea-vomiting reflex
- •Patients with good oral hygiene
排除标准
- •Patients with systemic disorders (diabetes, hypertension, radiotherapy/ chemotherapy, etc.)
- •Patients who have insufficient horizontal alveolar bone in the site where implant treatment is planned and who may lead to bone dehiscence after implant placement
- •Patients with collagen allergy
- •Those taking any medication that may affect wound healing
- •Those with bleeding disorders
- •Smokers who smoke more than 10 cigarettes a day
- •Poor oral hygiene
- •Those with vomiting-nausea reflex
- •Allergic to anti-inflammatory drugs
- •Patients with pregnancy/breastfeeding status.
研究组 & 干预措施
Control
Connective Tissue Graft
干预措施: Connective Tissue Graft (Other)
Test
Ribose Cross-Linked Thick Collagen Membrane
干预措施: Ribose Cross-Linked Thick Collagen Membrane (Other)
结局指标
主要结局
Peri-implant Mucosa Thickness
时间窗: From the beginning to the 3rd month
Changes in peri-implant mucosal thickness at baseline, month 1 and month 3
次要结局
未报告次要终点
研究者
Ömer Alperen Kırmızıgül
Assistant Prof Dr
Inonu University