Post-extraction Bone Regeneration of Partially Destroyed Sockets With Bovine Hydroxyapatite and rhBMP-2 Compared to Standard Guided Bone Regeneration Intervention (Bovine Hydroxyapatite and Collagen Membrane)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Bone height gain after tooth extraction and socket regeneration
研究概览
简要总结
Aim of the present investigation will be to evaluate the efficacy and safety of a granulate of rhBMP-2- loaded bovine bone mineral (rhBMP-2-BBM) as alveolar bone regeneration procedure following tooth extraction.
Forty (40) patients (both sex; age 18 years and older) requiring extraction of one (1) hopeless tooth (incisor, canine or premolar with loss of bone height of 5 mm or more in buccal alveolar wall), followed by alveolar bone regeneration (ABR) and placement of an endosteal implant will be enrolled into the study.
After exodontia, participants will be randomized and divided into two groups: in Experimental Group the socket will be grafted with rhBMP-2-BBM granules (1.0-0.25 mm); in Control Group the sockets will be grafted with Bio-Oss granules (1.0-0.25 mm) and covered with porcine collagen barrier membrane (Bio-Gide).
The end of the study will be fixed at the implantation surgery, seventeen (17) weeks after exodontia an ABR. Cone beam computed tomography (CBCT) scans will be made, immediately after (0), and sixteen (16) weeks after exodontia an ABR and the gain in alveolar bone height will be estimated and used as the primary outcome for comparison of both groups.
As secondary efficacy outcomes the change in alveolar bone width estimated from the CBCT scans; initial (0) and at seventeenth (17th) week after tooth extraction; the change in dental arch dimensions estimated from tridimensional models obtained from intraoral scans at one week before (-1) and sixteen (16) weeks exodontia an ABR; and the amounts of new bone, remnant material and connective tissue histomorphometrically measured in a bone biopsy collected during the implantation surgery at seventeenth (17th) week, will be considered.
Healing of gingival tissues at first (1st) and second (2nd) week and incidence of adverse reactions at first (1st), second (2nd) and sixteenth (16th) week, are used as secondary safety outcomes.
详细描述
It is an interventional and therapeutic clinical trial, as well as unicentric, prospective, parallel, controlled, random, and doble-blind (participants and outcomes assessors).
It is aimed to assess the efficacy and safety of an experimental combined medical device consisting of rhBMP-2-loaded bovine bone mineral (rhBMP-2-BBM) granules (1.0-0.25 mm) for alveolar bone regeneration (ABR) after extraction of a hopeless tooth (incisor, canine or premolar, both in upper and lower arch maxilla), having not less than 5 mm of bone height loss in vestibular wall, and planned insertion of an endosteal dental implant and prosthetic rehabilitation.
Participants will be recruited among patients attending the Dental Clinic of the Faculty of Dentistry of the Universidad Complutense de Madrid, Spain. There will be enrolled forty (40) voluntary (both sex; age 18 years and older) requiring extraction of one (1) hopeless tooth (incisor, canine or premolar with loss of bone height of five (5) mm or more in vestibular alveolar wall), followed by alveolar bone regeneration (ABR) and placement of an endosteal implant. Participants will be randomly and equitably distributed in two groups; Experimental and Control, each counting 20 participants.
Experimental group will be treated with rhBMP-2-BBM granules (1.0-0.25 mm) and Control group with Bio-Oss granules (1.0-0.25 mmm) and porcine collagen barrier membrane (Bio-Gide).
The enrollment will be open a maximum period of 12 months. Treatment and follow-up will last 18 weeks between the enrollment of one participant and the end of the study.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients with one tooth to be extracted, from incisor to premolar, and with buccal bone wall loss of 5 mm or more
- •Plaque index lower than 30%
- •Eighteen (18) years old and elder.
- •Willing to participate and written informed consent
排除标准
- •Heavy smokers (more than 20 cigarettes per day)
- •Plaque index greater than 30 %
- •Pathologies hindering interventions or influencing healing or host response
- •Inability to comply scheduled follow-up
- •Comprehension disability that compromises informed consent and compliance with medical instructions
- •Receptor of any other experimental treatments, actual or in past 30 days
- •Current pregnant patients or planning to get pregnant in short term
- •Breastfeeding mothers
结局指标
主要结局
Bone height gain after tooth extraction and socket regeneration
时间窗: 16 weeks
Difference between alveolar bone heights measured immediately after tooth extraction and 16 weeks after. Bone heights are measured from the CBCT scans obtained in the second and fifth visits using as reference a customized splint as elsewhere (PMID: 30883942)
次要结局
- Early Healing Index after tooth extraction and socket regeneration(1 and 2 weeks)
- Adverse reactions after tooth extraction and socket regeneration(1, 2 and 16 weeks)
- Need for second bone augmentation after tooth extraction and socket regeneration(17 weeks)
- Amounts of New Bone; Remnant Material and Connective Tissue after tooth extraction and socket regeneration(17 weeks)
- Bone width changes after tooth extraction and socket regeneration(16 weeks)
- Dental arch dimensional changes after tooth extraction and socket regeneration(16 weeks)