Flapless Application of Enamel Matrix Derivative in Class II Mandibular Furcation Defects: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Periodontal probing pocket depth (PPD) change
研究概览
简要总结
Patients diagnosed with stage III or IV periodontitis that exhibit mandibular first or second molars with increased periodontal probing depth (PPD > 4 mm) and class II buccal mandibular furcation defects (horizontal probing depth of >= 3 mm ) will be recruited. This study will be a non-inferiority, prospective, randomized, double-blind controlled clinical trial with a parallel design. Patient will be recruited from the clinics of the School of Dentistry at the Aristotle University of Thessaloniki and private dental practices in Thessaloniki, Greece. Initially, non-surgical periodontal treatment will be performed through scaling and root planning in combination with oral hygiene instructions and motivation. The re-evaluation will be performed 4-6 weeks following the treatment and the patients who meet the inclusion criteria will be included in the study. Patients will be randomly allocated at a 1:1 ratio to either subgingival debridement and flapless application of EMD (test group) into the affected furcation defect or to periodontal surgery in combination with EMD application (control group). Periodontal and radiographic parameters, patient reported outcomes, oral cavity measurements and gingival crevicular fluid will be collected before as well as up to 9 months following the treatment.
详细描述
The first step in periodontal therapy aims to successfully remove supragingival dental biofilm, improve oral hygiene and control potential risk factors. During the second step of treatment, the "cause-related therapy", non-surgical periodontal treatment consisting of subgingival debridement aiming to reduce plaque accumulation, calculus deposits, gingival inflammation, pocket depths is performed,which is effective for gaining attachment level. However, non-surgical periodontal treatment per se rarely translates into periodontal regeneration. In patients with severe periodontal disease residual periodontal pockets may remain after an initial therapy. Furcation defects often do not respond favourably to non-surgical periodontal therapy and are associated with elevated risk of progression. The elimination of these residual periodontal pockets can be achieved at the thirdstep of the treatment by resective or regenerative procedures based on the morphology of the defect or alternatively repeated subgingival instrumentation with or without adjunctive therapies can be carried out. Regeneration of the periodontal tissues includes cementum, periodontal ligament (PDL) and alveolar bone. Currently, several flap designs and biomaterials have been utilized and tested in the literature aiming at periodontal regeneration including bone grafts, bone substitute materials, growth factors, enamel matrix derivative proteins (EMD), guided tissue regeneration or even a combination of these materials. Although the application of EMD in conjunction with non-surgical periodontal treatment has shown a positive effect with evidence of regeneration, its effectiveness remains inconclusive.
Further studies in various disease conditions (intrabony defects, furcation defects, suprabony defects) are needed to confirm the potential benefit of adjunctive EMD application in combination with subgingival debridement (non surgical periodontal therapy). No study to our knowledge has tested the efficacy of flapless application of EMD in the healing of molars with furcation involvement.
Study design: Non-inferiority, double-blind, randomized, controlled clinical trial with parallel design.
Null Hypothesis: The adjunctive flapless use of enamel matrix derivative (EMD) during subgingival debridement in patients diagnosed with Stage III or IV periodontitis that exhibit class II buccal mandibular furcation involvement leads to inferior outcomes in clinical and radiographic as well as in biomarkers in comparison with surgical periodontal treatment with EMD.
Hypothesis: The adjunctive flapless use of enamel matrix derivative (EMD) during subgingival debridement in patients diagnosed with Stage III or IV periodontitis that exhibit class II buccal mandibular furcation involvement results in noninferior/equivalent outcome in clinical and radiographic variables as well as in biomarkers in comparison with surgical periodontal treatment with EMD.
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)
盲法说明
The selected sites will be randomly assigned to test and control groups using an online software for randomization. The therapist will be kept unaware of treatment allocation until the treatment. The outcomes assessor will be unaware of the treatment 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
- •Individuals of at least 18 years of age with a diagnosis of stage III or IV periodontitis.
- •Have at least one class II furcation defect with PPD >4 mm and horizontal probing depth of >= 3 mm in a mandibular first or second molar.
- •Teeth have to be vital or properly treated endodontically.
- •Gingival recession ≤ 2mm on furcation site
- •Proper oral hygiene: full-mouth plaque score (FMPS) ≤20%.
- •Systemically healthy (absence of systemic conditions such as diabetes mellitus that can affect the treatment outcome of periodontal therapy)
- •Ability to understand the study procedures and comply with them through the length of the study.
- •Given written informed consent form for participation in the study.
排除标准
- •Pregnant or lactating female (self-reported).
- •Current acute infection.
- •Non-surgical periodontal treatment within the last 6 months or/and surgical periodontal treatment the last 12 months before the initial pre-treatment.
- •Need for antibiotic premedication.
- •Antibiotic treatment in the previous 3 months.
- •Allergy to any materials or medications that could be used during or after the procedure.
- •Teeth having an improper endodontic therapy with clinical signs of infection or subgingival restorations.
- •Tooth mobility of 2nd and 3rd degree.
- •History of radiation therapy in the head and neck region.
- •Chronic use of medications that may alter the response of periodontal tissues.
- •Smoke ≥ 10 cigarettes/day.
研究组 & 干预措施
Subgingival debridement + Flapless Enamel Matrix Derivative
Subgingival debridement following a minimally-invasive non-surgical treatment (MINST) approach with flapless application of EMD
Root instrumentation under local anesthesia using mini hand instruments (mini curettes) and ultrasonic instruments with fine tips in the furcation area of mandibular first or second molars with class II buccal furcation defects. EDTA gel will be applied for 2 minutes on the affected root surfaces, followed by rinsing with saline and drying prior to the application of Emdogain® FL. Emdogain® FL has been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.
干预措施: Emdogain® FL (flapless Emdogain®) - Enamel Matrix Derivative (Other)
Periodontal surgery + Enamel Matrix Derivative
Periodontal surgery following a minimally-invasive surgical treatment (MIST) protocol with application of EMD
Following local anesthesia, minimal flap elevation on the buccal aspect of first or second molars associated with a grade II furcation defect will be performed.Removal of granulation tissues and root instrumentation with mini hand instruments (mini curettes) and ultrasonic instruments with fine tips in the furcation area will then be carried out. EDTA gel will be applied for 2 minutes on the affected root surfaces, followed by rinsing with saline and drying prior to the application of Emdogain®. Then, the surgical flaps will be positioned and sutured in order to completely cover the defects.
干预措施: Emdogain® - Enamel Matrix Derivative (Other)
结局指标
主要结局
Periodontal probing pocket depth (PPD) change
时间窗: 9 months after treatment
Changes in pocket probing depth will be measured using a periodontal probe. The depth of the sulcus will be assessed by gently inserting a graduated periodontal probe until resistance is encountered at the base of the sulcus. The depth from the free gingival margin to the base of the sulcus is measured in millimeters and represents PPD.
次要结局
- Horizontal and vertical furcation involvement change.(9 months after treatment)
- Bleeding on Probing (BOP) change(9 months after treatment)
- Gingival recession (REC) change(9 months after treatment)
- Furcation involvement grade change(9 months after treatment)
- Radiographic defect depth, height, root trunk and width.(9 months after treatment)
- Oral health-related quality of life(9 months after treatment)
- Patient-reported outcome measures(9 months after treatment)
- Periodontal clinical attachment level (CAL) change.(9 months after treatment)
- Levels of markers related to periodontal disease activity, inflammation as well as regeneration in the GCF.(9 months after treatment)
研究者
Georgios Chatzopoulos
PhD candidate
Aristotle University Of Thessaloniki