Maxillary Sinus Augmentation With Three Different Biomaterials: Histologic, Histomorphometric, Clinical and Patient Reported Outcomes From a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Histomorphometric parameters of the augmented bone (% of new bone, marrow, graft)
研究概览
简要总结
Background: Lateral maxillary sinus augmentation (MSA) is a predictable bone regeneration technique in case of atrophy of the posterior-upper maxilla. Aimed at obtaining quantity and quality of bone suitable for receiving osseointegrated implants, its success is largely due to the skill of the surgeon, but also to the characteristics of the biomaterial used.
Methods: Twenty-four patients needing MSA were included in the study. The patients were randomly allocated to 3 different groups: Anorganic Bovine Bone Mineral (ABBM) as control, Tricalcium Phosphate (TCP) with or without hyaluronic acid (HA) as test groups. Nine months after MSA bone biopsies were harvested for the histomorphometric analysis. Secondary outcomes were mean bone gain, intraoperative and post-operative complications, implant insertion torque, implant failure and patient related outcome measures (PROMs).
详细描述
The implant-prosthetic rehabilitation of the atrophic maxilla requires the creation of sufficient volumetric quantity of bone, through regeneration techniques, necessary to position the implants.
Maxillary sinus augmentation (MSA) is probably the most predictable and best performing technique.
The present randomized controlled study aims to evaluate and compare, histomorphometrically and clinically three different bone substitutes such as: ABBM, Tricalcium Phosphate (TCP) with or without the addition of hyaluronic acid (HA) that were used for lateral MSA. This study population will be followed until the 3rd year. This study describes histological differences between the three groups at 9 months.
All the patients enrolled in the study received a session of oral hygiene and a periodontal examination before the surgical procedure to obtain a more favorable oral environment for wound healing. A CBCT was mandatory for all included cases to verify that the maxillary sinus was clear and that the residual bone height was 3 mm or less. All the enrolled patients received 2 gr. of amoxicillin and clavulanic acid (or 600 mg. of clindamycin for those who were allergic to penicillins) as a pre-medication one-hour before surgery. All patients rinsed for 1 minute with 0.2% chlorhexidine mouthwash (and twice a day for the following 3 weeks). Local anesthesia was administered, a mid-crestal incision with mesial and distal release were performed to access the lateral bone wall of the maxillary sinus, subsequently, ultrasound bone surgery (Piezosurgery ®, Carasco, Italy) with specific tips was used for the bone window osteotomy (Figure 1-A). The Schneiderian membrane was reflected and lifted up medially with flat sinus curettes. Once the sinus membrane was completely lifted a bioabsorbable pericardium membrane (Smartbrane, Regedent AG, Zurich, Switzerland) was applied to protect it (Figure 1-B). The randomization sealed envelopes were opened and the clinician allocated the patients to one of the three experimental groups:
- Control group that received Demineralized Bovine Bone Mineral (Bio-Oss Cancellous, Geistlich, Wolhunsen, Switzerland);
- Test group 1 that received TCP with particle size ranging from 250 to 1000 µm (Osopia, Regedent, Zurich, Switzerland);
- Test group 2 that received TCP as in test group1 plus crosslinked Hyaluronic Acid (Hyadent BG, Regedent, Zurich, Switzerland) with a ratio 2 to 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The envelope with the group assignment will be opened by the surgeon at the time of surgery and the patient won't be informed.
The clinician who registers clinical parameters won't be informed of the group allocation. The histologist will receive biopsies with a numeric code but without informations of the graft material used.
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
- •need for maxillary sinus augmentation
- •18 years or older
- •residual ridge height less than 3mm
排除标准
- •full contraindication to implant surgery,
- •systemic diseases that could negatively influence wound healing;
- •heavy smokers (more than 10 cigarettes/day);
- •head and neck irradiation treatment;
- •uncontrolled diabetes;
- •chronic or acute sinus pathology;
- •uncontrolled periodontal disease;
- •full mouth plaque and bleeding score higher than 25%,
- •tooth extractions in the previous 2 months
结局指标
主要结局
Histomorphometric parameters of the augmented bone (% of new bone, marrow, graft)
时间窗: 9 months
Percentages of newly formed bone, marrow spaces and residual graft particles are reported.
Histomorphometric parameters of the augmented bone (descriptive)
时间窗: 9 months
Descriptive analysis of the specimen section at the microscope
次要结局
- Implant insertion torque measured in Ncm(9 months)
- Early implant failure(12 months)
- Intra-operative(During surgery)
- Post-operative complications(9 months)
- Mean bone gain measured at 9 months through CBCT evaluation(9 months)
- Patient reported outcome measures(9 months)
研究者
Antonio Barone
Professor
University of Pisa