The Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects - a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of patients/teeth displaying furcation closure.
研究概览
简要总结
The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone?
200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree >I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated.
详细描述
The study will be conducted as a randomized controlled trial with a 12-month follow-up at multiple clinical centers throughout Europe. All study-related procedures are to be performed by specialists in periodontics or clinicians in specialist training. 200 patients with ≥1 molar with a furcation defect degree II (pre-surgical assessment) will be enrolled in the study. Following the primary evaluation at 12 months, study participants will be followed up to 10 years.
Preparatory phase Prior to surgery, patients will be provided with tailored non-surgical periodontal therapy including instructions in self-performed plaque control measures and supra- and subgingival instrumentation. The preparatory phase is concluded by an examination 8-16 weeks after completion of the non-surgical instrumentation.
Surgical intervention Following local anesthesia, full thickness flaps at target molars will be elevated and inflamed tissues are removed. Root surfaces are then instrumented using an ultra-sonic device with a standardized tip under irrigation with saline. Upon completion of root instrumentation, group allocation is revealed and a bone substitute material will be placed in the furcation defect to the level of the outer contour of the roots in the test group. Flaps will be repositioned and sutured to cover the entirety of the furcation area aiming for primary closure. The same procedure, omitting the placement of the bone substitute material, will be performed in the control group.
Patients will refrain from mechanical self-performed plaque control measures in the surgical area for 4 weeks post-surgery. During this period, daily rinsing with a 0.2% solution of chlorhexidine digluconate is prescribed.
Follow-up Sutures will be removed after two weeks and patient-reported experience (PRE) is scored. Patients will then be seen for oral hygiene instructions at 4 weeks and for supportive periodontal therapy at 3, 6, 9 and 12 months. Treatment and patient-reported outcomes (PROs) will be evaluated at 6 and 12 months. Additional examinations are carried out at 3, 5, 7 and 10 years.
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)
盲法说明
Clinical assessments following intervention will be conducted by assessors unaware of group allocation.
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 should present with at least one surgically accessible molar (in tooth position 6 or 7) diagnosed with a single furcation defect degree II (at any aspect).
- •Following initial periodontal therapy, teeth to be included should present with one site with furcation defect degree II in combination with:
- •Bleeding on probing
- •Probing pocket depth of ≥6 mm
- •Soft tissue coverage of the furcation entrance Patients should present with a full mouth plaque score ≤25%.
排除标准
- •Multiple deep furcation defects (degree II - III) at the same tooth
- •Vertical attachment loss >50% at aspects not facing the furcation defect
- •Defects presenting with apico-marginal communication
- •Intake of systemic antibiotics within 6 months
- •Systemic conditions/medication impeding surgical intervention (e.g. uncontrolled diabetes, immunosuppressive medication)
研究组 & 干预措施
Access flap + bone substitute
Furcation defect will be treated by access flap debridement followed by application of a bone substitute material.
干预措施: Access flap & surgical debridement (Procedure)
Access flap + bone substitute
Furcation defect will be treated by access flap debridement followed by application of a bone substitute material.
干预措施: Application of bone substitute material (BioOss Collagen) (Procedure)
Access flap
Furcation defect will be treated by access flap debridement alone.
干预措施: Access flap & surgical debridement (Procedure)
结局指标
主要结局
Proportion of patients/teeth displaying furcation closure.
时间窗: 10 years.
Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.
次要结局
- Changes in bleeding on probing.(10 years.)
- Changes in vertical and horizontal clinical attachment level.(10 years.)
- Changes in marginal soft tissue levels.(10 years.)
- Tooth loss.(10 years.)
- Need for retreatment.(10 years.)
- Change of inflammatory markers.(6 weeks.)
- Patient satisfaction assessed by visual analogue scale.(12 months.)
- Changes in probing pocket depth.(10 years.)
- Changes in radiographic bone levels.(10 years.)
- Patient discomfort as expressed on a visual analogue scale.(6 months.)
- Esthetic appreciation as expressed on a visual analogue scale.(12 months.)
- Rate of adverse events.(12 months.)