Comparison of the Guided Tissue Regeneration (GTR) Procedure Alone and in Combination With Immediate Orthodontic Tooth Movement (OTM) in the Treatment of Non-containing and Wide Intrabony Periodontal Defects: a Prospective RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Amount of graft material by means of histomorphometry
研究概览
简要总结
The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of a GTR procedure, when it is combined with an immediate orthodontic tooth movement or used alone. Clinical, radiological and reentry (histological) evaluation of a regenerative surgical method (GTR + grafting material) with different postsurgical healing patterns in the treatment of wide, non-containing intrabony defects.
详细描述
There is limited histological data in literature on the behavior of xenogeneic graft materials in intrabony defects used in periodontal regenerative therapy followed by orthodontic tooth movement (OTM). This clinical study aims to clinically and histologically evaluate the healing response of the periodontal tissues and the healing pattern of a non-resorbable graft material, when they are exposed to orthodontic forces. Therefore teeth presenting non-contained intrabony defects in combination with pathologic tooth migration (PTM) are included in this prospective clinical study. Guided tissue regeneration (GTR) with the application of deproteinized bovine bone mineral (DBBM) and a resorbable collagen membrane is utilized to surgically treat the periodontal defects, which is followed by a random allocation of the patients into test or control group. Subject teeth undergo an early initiated orthodontic treatment after surgery or stay splinted without any tooth movement in the latter groups, respectively. Teeth in test group can be further divided into subgroups, depending if they are moved toward to the former defect (pressure site) or moved away from the defect (tension site). After 9 months of healing a reentry surgery is performed, when a biopsy core is removed with a microtrephine from the previous defect site. The sample is evaluated by means of histology supplemented with histomorphometry, which is the primary outcome variable. Periodontal clinical parameters measured at baseline and at 9 months serves for secondary outcomes. Several studies confirmed the success of graft materials in such comprehensive treatment approaches clinically, but we lack the human histologically proved data, whether DBBM bone substitute can be used safely when the tooth is exposed to OTM. Our main question is how orthodontic induced bone remodelling interferes with these graft particles, can they heal the same or even better compared to control sites. Tissue response might be different also in the case of the two test subgroups.
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
The histologist is blinded to the study protocol
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontitis with intrabony defect (Intrabony component ≥ 4mm, defect radiological angulation > 25°, 1 or max. 2 bony walls (no buccal bony wall), non-containing defect), no class III. furcation involved teeth
- •Selected tooth must be in a traumatic occlusion or not in a gnathologically correct bite (migrated, elongated, tilted tooth, etc.).
- •Patients must not be heavy smokers (<5 cigarettes/day).
- •Full mouth plaque and bleeding scores (FMPS and FMBS) of <20% (O'Leary et al. 1972).
- •The patient is able to comply with the study -related procedures (i.e. good level of oral hygiene, follow-up procedures).
- •The patient is able to fully understand the nature of the study, signed informed consent.
排除标准
- •Pregnant women.
- •Participation in another clinical study within 30 days prior to study start.
- •Alcoholism, drug dependency, heavy smoking (>5 cigarettes/day).
- •Known infection with HIV, HBV, or HCV.
- •Patients requiring chemo- or radiotherapy.
- •Previous or current radiotherapy of the head.
- •Uncontrolled or insulin-dependent diabetes mellitus
- •Clinically relevant osteoporosis or systemic disease affecting bone metabolism
- •Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months.
- •Clinically relevant blood coagulation disorder.
- •Previous or current treatment with systemic corticosteroids (within 2 months prior to screening visit) of more than 5 mg/day prednisone equivalent.
- •Previous or current therapy with bisphosphonates at least for 30 days within the last 12 months before screening visit.
结局指标
主要结局
Amount of graft material by means of histomorphometry
时间窗: 9 months postoperatively
The percentage of graft material (BioOss, Geistlich Pharma AG, Wolhusen) of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention
Amount of newly formed bone by means of histomorphometry
时间窗: 9 months postoperatively
The percentage of newly formed bone of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention
Amount of connective tissue by means of histomorphometry
时间窗: 9 months postoperatively
The percentage of connective tissue of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention
次要结局
- CAL(9 months postoperatively)
- PPD(9 months postoperatively)
- GR(9 months postoperatively)
- Bone loss(9 months postoperatively)
- Intrabony fill(9 months postoperatively)
- Bone gain(9 months postoperatively)
研究者
Pal Nagy
Assistant Professor
Semmelweis University