Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in radiographic bone fill
研究概览
简要总结
Objective: the objective of the present randomized clinical trial is to compare changes in radiographic peri-implant bone defect fill after regeneration of peri-implant intrabony defects with a submerged versus a non-submerged protocol.
Material and Methods: this project is a randomized controlled clinical trial, double blind, with a parallel groups design. Thirty-six patients presenting with peri-implantitis subsidiary of regenerative treatment will be recruited. After subjects have been given informed consent, they will be randomized to test or control group. All patients will undergo a session of non-surgical peri-implantitis therapy consisting on prostheses removal and implant debridement with ultrasounds, curettes and air-abrasive under local anaesthesia. Patients in test group will have their prostheses removed and the mucosa surrounding the affected implants will be let heal covering the implants, while patients in control group will have their prostheses installed again after the non-surgical therapy. Six to eight weeks later, all subjects will undergo regenerative treatment with the use of a bone substitute, a collagen membrane and fixation pins, and in control group tissues will heal following the non-submerged protocol, meanwhile subjects in test group will undergo submerged healing. Six months later, subjects in test group will have their prostheses reconnected to the regenerated implants. All patients will undergo periodontal and peri-implant maintenance therapy every three months during follow-up. Radiographic assessment of vertical bone level changes (primary outcome), clinical status of peri-implant tissues, changes in soft tissues margin, patient related outcomes and adverse events will be assessed at 3, 6 and 12 months after peri-implantitis regenerative surgery.
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)
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
- •Patients diagnosed of peri-implantitis requiring surgical therapy
- •The periapical radiographic study demonstrates an intra-bony component greater than 3 mm at the affected implant
- •There is at least 2 mm of keratinized mucosa around the affected implant
- •Intrasurgically, peri-implant defects must be type Ia, Ib, Ic and Ie (according to Schwarz et al. 2007)
- •Affected implants must be two-piece implants to allow for the submerged protocol
- •Affected implant supported restorations must be screw-retained or cemented, and should allow for prostheses removal
排除标准
- •Patients with untreated periodontitis
- •Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
- •Metabolic disorders such as osteoporosis
- •History of uncontrolled endocrine disorders
- •History of leukocyte dysfunction and deficiencies
- •History of immunodeficiency syndromes
- •History of neoplastic disease requiring the use of radiation of chemotherapy
- •History of renal failure
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- •Alcoholism or drug abuse
- •Smokers of more than 10 cigarettes per day, cigar equivalents or tobacco chewers
- •Any other condition or circumstance that, in the opinion of the investigator, would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability
研究组 & 干预措施
Submerged healing
Bone regeneration of peri-implantitis defects following a submerged healing
干预措施: Submerged healing (Procedure)
Non-submerged healing
Bone regeneration of peri-implantitis defects following a non-submerged healing
干预措施: Non-submerged healing (Procedure)
结局指标
主要结局
Changes in radiographic bone fill
时间窗: Baseline, 3 months, 6 months and 12 months post-surgery
Changes in radiographic bone fill measured from the implant shoulder to the first bone to implant contact with ImageJ software, in parallelized periapical x-rays with individual silicone bite blocks
次要结局
- Changes in bone probing depth(At baseline, after non-surgical therapy and 12 months post-surgery)
- Soft tissue healing scores(1 week, 2 weeks and 4 weeks post-surgery)
- Changes in pocket probing depth(At baseline, after non-surgical therapy, 6 months and 12 months post-surgery)
- Pain assessment(1 week, 2 weeks and 4 weeks post-surgery)
- Oral Health Impact Profile (OHIP-14)(Baseline, 3 months, 6 months and 12 months post-surgery)
- Changes in modified plaque index(At baseline, after non-surgical therapy, 6 months and 12 months post-surgery)
- Changes in full mouth bleeding scores(At baseline, after non-surgical therapy, 6 months and 12 months post-surgery)
- Adverse events´ occurrence(Up to 12 months post-surgery)
研究者
Ana Molina Villar
Investigator
Universidad Complutense de Madrid