Treatment of Mandibular Type II Furcations Using Bovine-derived Bone Xenograft With or Without a Collagen Membrane: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 主要终点
- Horizontal Probing Attachment Level
研究概览
简要总结
The aim of the study was to perform a randomized controlled clinical study in order to compare the effects of a bovine derived xenograft (with 10% collagen) + a bioabsorbable membrane (control group, CG) vs a bovine derived xenograft (with 10% collagen) alone (test group, TG) on the surgical treatment of mandibular type II furcation defects.
详细描述
The aim of the study was to perform a randomized controlled clinical study in order to compare the effects of a bovine derived xenograft (with 10% collagen) + a bioabsorbable membrane (control group, CG) vs a bovine derived xenograft (with 10% collagen) alone (test group, TG) on the surgical treatment of mandibular type II furcation defects. The patients all underwent the same surgical intervention with the only difference between the two groups being the use or not of a collagen membrane.
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 (Participant)
盲法说明
The patients didn't know whether they were the control or test group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic periodontitis
- •Initial phase (oral hygiene instructions + full mouth scaling and root planing) performed at least eight weeks before inclusion
- •Full-mouth plaque score ≦ 20% (at least eight weeks after initial phase and during the whole treatment)
- •Clinical evidence of vestibular or lingual mandibular Class II furcation defects (≧ 3mm of horizontal probing depth)
- •Presence of at least 2 mm of keratinized gingiva on the selected tooth surface facing the furcation
- •Tooth vitality confirmed by clinical tests (cold testing)
排除标准
- •Presence of any systemic disease
- •Devitalized tooth or tooth presenting periapical or pulpar pathology (confirmed with a retro-alveolar radiograph)
- •Allergies to any of the products used in the present study
- •Pregnant or breastfeeding women
- •History or current RX therapy
研究组 & 干预措施
Control group
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
干预措施: Open flap surgery (Procedure)
Control group
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
干预措施: Bio-oss collagen (Device)
Control group
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen + Bio-gide
干预措施: Bio-gide (Device)
Test group
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone
干预措施: Open flap surgery (Procedure)
Test group
Open flap surgery on mandibular type II furcations treated with Bio-oss collagen alone
干预措施: Bio-gide (Device)
结局指标
主要结局
Horizontal Probing Attachment Level
时间窗: 6 months
PAL-H
次要结局
未报告次要终点