A Comparative, Randomized, Prospective, Clinical Study to Evaluate the Facial Bone and Esthetic Outcome of Buccal Augmentation Bone Grafting Techniques in Early (Type 2) Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Facial bone thickness
研究概览
简要总结
Total of 48 subjects were randomly assigned to treatment groups:
UT Health Science Center at San Antonio Chi Mei Medical Center, Tainan, Taiwan
Patients require a maxillary non-molar extraction site that is planned to be replaced by a dental implant and crown. This includes Straumann BL SLActive: Narrow (3.3mm) & Regular (4.1mm) Crossfit implants in all available lengths.
Patients were randomly selected to receive either FDBA (test) or Autogenous bone + DBBM (control/standard) for contour augmentation.
详细描述
This comparative, randomized, prospective clinical study is designed to compare clinical outcomes and facial bone height and thickness of two different bone grafting techniques after augmentation in (Type 2) early implant placement.
Human subjects who could potentially qualify with the said inclusion criteria will be evaluated and screened. 24 human subjects who qualify for the procedure will have a thorough evaluation performed after obtaining consent from the patient. All subjects will require extraction of maxillary teeth (incisors, canines, premolars), followed by early implant placement of the missing teeth after 4 to 8 weeks extraction.
There will be two subject groups in this study in which the 24 human subjects in will randomly be placed by selecting the number "1" or "2" from a hat. 24 human subjects will be divided into two groups including 12 subjects using control group design and 12 subjects using test group design. 12 subjects will be placed randomly into Group 1 and will undergo the flapless extraction and early implant placement with GBR procedure using the control group design. 12 subjects will be placed randomly into Group 2 and will undergo the flapless extraction and early implant placement with GBR procedure using the test group design.
During the implant placement visit after 4 to 8 weeks of extraction, patient will be asked to select a number from a hat. If the number showed "1" as a control group, autograft , BBM and collagen membrane will be used as GBR materials after implant placement. If the number showed "2" as a test group, FDBA and collagen membrane will be used as GBR materials after implant placement.
Extraction sites will include maxillary teeth (11,12,13,14,15,21,22,23,24,25 according to FDI) having intact adjacent teeth. Implants placed for this study will have a SLActive surface, bone level design, Straumann NC 3.3mm or RC 4.1mm in diameter at all available implant lengths.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient is 18 years or older.
- •Non-smoker or patient has smoking habit and < 1 pack per day.
- •Ability to understand and provide informed consent before starting the study.
- •Ability and willingness to comply with all study requirements.
- •The patient, if of child-bearing potential, has a negative urine pregnancy test.
- •Adequate oral hygiene to allow for implant therapy consistent with standards of care.
- •Adequate primary stability following early implant placement protocols utilizing Straumann Bone Level implants NC 3.3mm or RC 4.1mm in diameter at all available implant lengths.
- •One or more teeth in maxilla (11,12,13,14,15,21,22,23,24,25 according to FDI) has been identified as having a hopeless prognosis requiring extraction leading to a single-tooth gap requiring implant placement as determined by clinician.
- •Implant site that has a defect and requires bone augmentation. This will be determined by measuring on the CBCT image the available space for the implant and whether or not there is enough bone width where the implant is to be placed.
排除标准
- •Patient reports current smoking habit > 1 pack per day or tobacco chewing use.
- •History of alcoholism or drug abuse within the past 5 years.
- •Severe bruxism or clenching habits.
- •Patient has significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
- •History of HIV infection, Hepatitis B or C.
- •Patients with a history of systemic disease that precludes standard dental implant therapy.
- •Presence of local inflammation or mucosal diseases such as lichen planus
- •Patient history consistent with high risk for subacute bacterial endocarditis
- •Current hematological disorder or coumadin (or similar) therapy
- •Patient currently undergoing chemotherapy
- •Patient history of radiation treatment to the head or neck
- •Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis
- •Pregnant or breastfeeding women
研究组 & 干预措施
Control
Guided bone regeneration with Bovine Bone Mineral
干预措施: Guided bone regeneration with Bovine Bone Mineral (Procedure)
Experimental
Guided bone regeneration with freeze dried bone allograft
干预措施: Guided bone regeneration with freeze dried bone allograft (Procedure)
结局指标
主要结局
Facial bone thickness
时间窗: Measured at 1 year post-loading
Facial bone thickness 1 year post-loading at 1, 3, and 5mm from the implant platform
次要结局
- Change in facial bone thickness(Between implant placement and 1 year post-loading)
- mPI measurement(Measured at 6 and 12-months post-loading)
- PD measurement(Measured at 6 and 12-months post-loading)
- mSBI measurement(Measured at 6 and 12-months post-loading)
- KM measurement(Measured at 6 and 12-months post-loading)