Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants. A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in marginal alveolar crest
研究概览
简要总结
The main objective of this study is to evaluate the efficacy of an acellular dermal matrix membrane to increase the peri-implant soft tissue thickness and to reduce marginal bone loss during non-submerged implant placement, as compared with the standard protocol for implant placement. The test hypothesis is that placing an acellular dermal matrix membrane simultaneous to implant placement in the posterior mandible, will increase the soft tissue thickness and consequently reduce the marginal bone level changes.
The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up
详细描述
The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up. The randomization sequence will be created using a computer-generated list by an independent researcher. Allocation concealment will be kept by means of opaque sealed envelopes that will be open by one of the researchers during surgery, and revealed to the operator immediately after implant insertion.
All patients will receive standardized oral hygiene instructions consisting on the use of a manual or power-driven toothbrush and specific interdental brushes. Then, patients will be randomized to one of the following groups:
- Test Group :Mucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs)
- Control Group: All the procedures will be the same as in the Test Group, with the only difference that no attempt to thicken the mucosa with the acellular dermal matrix will be performed.
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 (Investigator, Outcomes Assessor)
盲法说明
Clinical examiners evaluating and recording the outcome measurements will be masked to the treatment allocation and the patients will be asked not to reveal their treatment assignment to the examiners.
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
- •Systemically healthy
- •Periodontally healthy or with stable treated periodontitis and good oral hygiene (Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) ≤ 15%, measured at six sites per tooth)
- •Need for one or two implants in the posterior mandible (maximum of three missing teeth).
- •Enough bone availability to place an implant with a minimum diameter of 3.8 mm and at least 7 mm length.
- •Non-smoker or smokers < 10 cig/day (self-reported).
- •Ability to understand the study procedures and to comply with them to the entire length of the study.
排除标准
- •Subjects with uncontrolled systemic diseases (ASA type III).
- •Subjects taking medications with immunosuppressors, bisphosphonates or high doses of corticosteroids; current drug or alcohol use or dependence that could interfere with adherence to study requirements.
- •Pregnant or lactating women.
- •Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs.
- •History of cancer requiring radiotherapy or chemotherapy during the last 5 years.
- •Local inflammation (including untreated periodontitis)
- •Severe bruxism or clenching habits.
- •Any kind of bone augmentation performed on the implant site, with a healing period <6 months
- •Less than 4 mm of keratinized mucosa
- •Post-extraction sites with <12 weeks of healing
- •Lack of primary implant stability assessed intrasurgically.
结局指标
主要结局
Change in marginal alveolar crest
时间窗: 1 year
The primary outcome variable of this trial is the change in the marginal alveolar crest after the surgical intervention, assessed by the radiographic change of interproximal bone levels. It will be assessed with periapical radiographs, immediately after surgery and at 6 months and 12 months after loading, by means of computer image analysis software (Image J, National Institute of Health \[NIH\], Bethesda, Maryland). The calibration of the periapical radiographs will be performed using the distance between two implant threads or the length of the implant.
次要结局
- Duration of surgical intervention.(from the tooth extraction to the end of the surgery)
- Change of keratinized tissue width(1 year)
- Change in peri-implant soft tissue thickness(1 year)
- Change of the peri-implant soft tissue health(1 year)
- Interproximal recession(1 year)
- Wound healing(After a week)
- Full-mouth plaque and bleeding scores(1 year)
- Patient-reported outcome measures for pain and discomfort(14 days)
- Patient Global Assessment(1 year)