Evaluation of Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Two Different Transcrestal Sinus Floor Elevation Approaches: A Multi-Center, Double Blind, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Mean periapical sinus bone level changes measured in mm using periapical radiographs and CT scans.
研究概览
简要总结
Sixty patients with partially edentulous posterior maxilla requiring a transcrestal sinus floor elevation technique to insert one implant will be selected. The purpose of this multi-center, prospective, double blind, and randomized investigation is to analyze a platform switched implant when placed at limited maxillary residual bone height with low bone density compared to a platform matching implant with or without bone graft material.
详细描述
Approximately 60 subjects who require at least one posterior maxilla implant in the areas of the second pre-molars or (first or second) molars with 6 to 9 mm of crestal bone below the sinus floor, as determined on the computerized axial tomographic (CT) scan, will be recruited for the study. Subjects will receive dental implants to replace a missing tooth (second pre-molar or first/second molar) on one side of the maxillary arch. Each subject will receive one type of implant: platform switched (PS) or platform matching (PM). Each site will receive either a bone graft material composed of anorganic bovine bone mineralized (ABBM, Bio-Oss, Geistlich Pharma) or no graft material (collagen membrane used for wound healing (Collatape, Zimmer)). At implant placement surgery and post-surgical follow-ups, the treated site will be examined, clinically measured, and radiographs and photographs will be taken.
The central hypothesis is that the mean crestal bone level for the platform switched (test implants) implants will be superior to the mean crestal bone level for the platform matching (control implants) implants when placed in limited maxillary residual bone in the posterior regions, regardless of the use of bone graft material or 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have read, understood and signed an informed consent form.
- •Subjects must be 18 to 70 years of age.
- •Subjects must be able and willing to follow study procedures and instructions.
- •Subject must maintain good oral hygiene.
- •Subjects must have a single tooth missing in the pre-molar or molar region of the maxilla (ADA tooth positions 2-4 and 13-15; FDI tooth positions 15-17 and 25-27).
- •The mesio-distal distance of the tooth gap at bone level must be at least 6.8 mm to allow for placement of the Ø3.8 mm implant with a minimal distance of 1.5 mm from the implant shoulder to the adjacent tooth at bone level. A minimum of 7.8 mm of buccal-lingual ridge to allow 2 mm of buccal and lingual plate will be required.
- •No apical disorder/inflammation at the area of the implant site.
- •Residual bone height ranging from 6 to 9 mm.
- •The implant must penetrate at least 2 mm into the sinus on the mesial or distal sides.
- •Sufficient bone width in the edentulous region (≥ 6mm).
- •Subjects must be committed to the study and attend the required follow-up visits.
排除标准
- •Subjects with a systemic disease that would preclude dental implant surgery (e.g. serious internal medical problems, disorders of bone metabolism, uncontrolled bleeding disorders, weakened immune system, illness requiring periodic use of steroids, uncontrollable endocrine disorders, uncontrolled diabetes).
- •Subjects who have failed to maintain good plaque control.
- •Subjects with any contraindications for oral surgical procedures (e.g. inadequate wound healing capacity, poor oral hygiene, maxillary and mandibular growth not completed, xerostomia).
- •Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site.
- •Subjects presenting with maxillary sinus pathology.
- •Subjects with a history of local irradiation therapy in the head/neck region.
- •Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction.
- •Subjects receiving, or having a history of receiving intravenous or subcutaneous antiresorptive agents associated with osteonecrosis of the jaw, such as bisphosphonates.
- •Oblique sinus floor (> 45 inclination).
- •Subjects with any untreated endodontic lesions or untreated periodontal disease.
- •Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew tobacco, including within 3 months prior to enrollment.
- •Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene.
- •Subjects who are pregnant or intending to become pregnant during the duration of the study.
- •Subjects requiring bone augmentation or socket grafting prior to surgery.
- •Subject allergic to collagen or porcine derived products.
- •Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non- compliance or unreliability.
研究组 & 干预措施
Arm 1
Transcrestal Sinus Floor Elevation using platform switched implant with bone graft material.
干预措施: Anorganic Bovine Bone Graft Material (Device)
Arm 1
Transcrestal Sinus Floor Elevation using platform switched implant with bone graft material.
干预措施: Shelta Platform Switching Premium Implants (Device)
Arm 2
Transcrestal Sinus Floor Elevation using platform switched implant with no bone graft material.
干预措施: Collagen Membrane (Device)
Arm 2
Transcrestal Sinus Floor Elevation using platform switched implant with no bone graft material.
干预措施: Shelta Platform Switching Premium Implants (Device)
Arm 3
Transcrestal Sinus Floor Elevation using platform matching implant with bone graft material.
干预措施: Anorganic Bovine Bone Graft Material (Device)
Arm 3
Transcrestal Sinus Floor Elevation using platform matching implant with bone graft material.
干预措施: Shelta Platform Matching Premium Implants (Device)
Arm 4
Transcrestal Sinus Floor Elevation using platform matching implant with no bone graft material.
干预措施: Collagen Membrane (Device)
Arm 4
Transcrestal Sinus Floor Elevation using platform matching implant with no bone graft material.
干预措施: Shelta Platform Matching Premium Implants (Device)
结局指标
主要结局
Mean periapical sinus bone level changes measured in mm using periapical radiographs and CT scans.
时间窗: 12 months
Mean periapical sinus bone level change between implant placement and 12 months will be determined by radiographic measurement (using periapical radiographs and CT scans) following placement of a platform switched implant or platform matching implant in the posterior region of the maxilla, with bone graft material or without bone graft material.
Implant survival measured through observation.
时间窗: 12 months
Implant survival will be measured at implant loading and 12 months following implant placement will be assessed through clinical observation.
Implant success rate measured by percentage.
时间窗: 12 months
Implant success rate will be assessed at implant loading and 12 months following implant placement measured by percentage.
Mean crestal bone level changes measured in mm using periapical radiographs and CT scans.
时间窗: 12 months
Mean crestal bone level change around the implants will be determined by periapical radiographs of mesial and distal bone levels. CT scans will be used to determine buccal and lingual bone level change between implant placement and 12 months, following placement of a platform switched implants or platform matching implants.
次要结局
- Changes residual crestal bone height measured in mm compared to implant success.(12 months)
- Bleeding on probing measured by present or not present.(12 months)
- Implant Stability Quotient (ISQ) measured in N/cm.(6 months)
- Changes in sinus anatomy measured in mm compared to implant survival.(12 months)
- Changes in sinus anatomy measured in mm compared to crestal bone changes.(12 months)
- Changes in sinus anatomy measured in mm compared to implant stability.(12 months)
- Changes residual crestal bone height measured in mm compared to implant stability.(12 months)
- Crestal bone height changes measured in mm using periapical radiographs.(12 months)
- Gingival Recession measured in mm.(12 months)
- Changes in sinus anatomy measured in mm compared to implant success.(12 months)
- Changes residual crestal bone height measured in mm compared to implant survival.(12 months)
- Periodontal Pocket Depths measured in mm.(12 months)
- Subject satisfaction assessed through questionnaire.(12 months)
- Changes residual crestal bone height measured in mm compaierd to sinus bone levels.(12 months)
研究者
Ismael Khouly
Associate Director of Periodontology & Implant Dentistry
NYU College of Dentistry