A Randomized Controlled Trial Comparing Hemostatic Gelatin Sponge to Collagen Matrix as Socket Seal in Alveolar Ridge Preservation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Changes in soft tissue height at the buccal and lingual aspect
研究概览
简要总结
Patients in need of extraction of two teeth followed by implant replacement, with > 50% buccal bone present following tooth extraction and with 1 or 2 neighbouring teeth present, were invited to participate in an intra-subject RCT comparing hemostatic gelatin sponge to collagen matrix as socket seal in alveolar ridge preservation.
The sample size calculation indicated 16 patients to be included per group. To compensate for dropouts, this number was increased to 20 patients per group. Coincidence (coin flip) determined which site is treated with the gelatine sponge and which with the collagen matrix.
Teeth were extracted without flap elevation. When deemed necessary by the clinician, papillary incisions were made for minimal reflection, which enabled to place elevators without damaging soft tissues. Buccal soft tissues were never raised. Following wound debridement and rinsing, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM.
Changes in soft tissue height at the buccal and oral aspect is the primary outcome. A small-field low-dose CBCT image was taken at T0 (immediately postop) and T3 (4 months). Those images were superimposed in specialized software (OnDemand3D, Cybermed Inc., Seoul, South-Korea). Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.
Secondary outcomes included wound healing and closure in the first three weeks, changes in hard and soft tissues and mucosal scarring after 4 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
It concerns a surgical intervention. Hence, the treating surgeon cannot be masked. As each patient receives both the control and test treatment at the same moment, the patient is masked. The investigators and outcome assessors are masked.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good oral hygiene (plaque score < 25%)
- •1 or 2 neighbouring teeth present
- •in need for extraction of two teeth, followed by implant placement
- •>50% bone present
- •signed informed consent
排除标准
- •systematic diseases
- •history of periodontitis
- •untreated caries lesions
- •pregnancy
结局指标
主要结局
Changes in soft tissue height at the buccal and lingual aspect
时间窗: T0 (immediately post-op) and T3 (4 months)
A CBCT was taken at T0 (immediately post-op) and T3 (4 months). Since soft tissues were separated from hard tissues by using lip retractors and a backward position of the tongue, soft tissue height could be assessed on CBCT images. Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.
次要结局
- Mucosal scarring(T3 (4 months))
- Changes in buccal soft tissue profile(T0 (immediately post-op) and T3 (4 months))
- Wound dimension(T0 (immediately post-op), T1 (1 week) and T3 (4 months))
- Wound healing(T1 (1 week), T2 (3 weeks) and T3 (4 months))