NCT05168891已完成不适用
"Surgical Vs. Non-surgical Peri-implant Therapy: a 12-month Randomized Controlled Clinical Trial"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Defect fil (mm)
研究概览
简要总结
The aim of this randomized clinical trial is to evaluate the effectiveness, in terms of clinical and radiographic changes, of non-surgical peri-implant therapy (mechanical/chemical) versus regenerative surgical therapy (xenograft and collagen membrane), after a follow-up period of 12 months.
详细描述
- Objectives 1.1 Primary objective
- To evaluate the radiographic bone fill of non-surgical mechanical debridement combined with systemic antibiotic therapy, compared to the adjunctive regenerative surgical therapy in the treatment of infraosseous peri-implant defects.
1.2 Secondary objectives
- To evaluate the following clinical parameters: modified plaque index (mPI), modified - Bleeding Index (mBI), BOP, SOP, implant PPD, mucosal recession (MR).
- To evaluate the following radiographic outcomes: bone level (BL), intrabony defect (ID)
- To evaluate the following Patient reported outcome measures (PROMs): Oral health impact profile (OHIP-14sp), VAS Score, pain medication.
- Hypothesis
- The non-surgical mechanical and antibiotic therapy of peri-implantitis in the treatment of infraosseous defects around implants will achieve similar radiographic bone fill and similar clinical results, when compared to the same protocol and the adjunction of a regenerative surgical therapy by means of xenograft plus a collagen membrane.
- Material y methods:
3.1 Study design: This is a prospective, single-blinded, randomized, controlled clinical trial with 1-year follow-up.
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
- Single (Investigator)
盲法说明
Due to the nature of the study design, neither the patient nor the operator will be blinded. On the other hand, two blinded investigators will collect and record all the clinical and radiological measurements, respectively.
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
- •Men and women over 18 years old.
- •Presence of ≥ 1 endosseous implants with clinical and radiographic signs of peri- implantitis [i.e., peri-implant bone level ≥ 3mm apical to the most coronal portion of the intraosseous part of the implant, PPD ≥ 6 mm, and presence of bleeding and/or suppuration on gentle probing (BOP/SOP).
- •Implant function time ≥ 1 year.
- •Vertical peri-implant bone defect (defects of 2-3 walls and a defect depth ≥ 3 mm).
- •Presence of at least 2 mm of keratinized mucosa.
- •Absence of active periodontal disease.
- •Good level of oral hygiene (Plaque Index < 25%) (O'Leary et al. 1972)
- •Screw-retained single-unit crowns and partial dental prosthesis that allowed correct access for brushing; and, if not,
- •Prostheses that could be modified.
- •Absence of occlusal overload.
排除标准
- •Clinical implant mobility.
- •Radiographic peri-implant bone loss > 50%.
- •Pregnancy or lactating females.
- •Any medical condition which contraindicated surgical peri-implant therapy.
- •Previous non-surgical treatment (i.e., subgingival debridement) of the affected implants at least 12 months before.
- •Previous surgical treatment of the affected implants.
- •Systemic diseases, medications, or conditions that may compromise wound healing influencing the outcome of the therapy.
- •Known allergy or intolerance to metronidazole or ibuprofeno.
- •Use of systemic antibiotics during the previous 3 months.
- •Use of systemic antibiotics for endocarditis prophylaxis.
- •Smoking more than 10 cigarettes/day.
结局指标
主要结局
Defect fil (mm)
时间窗: 12 months after therapy
peri-implant defect fill (≥1.0 mm and \< 1 mm) from radiographic baseline
次要结局
- Implant Pocket probing depth (PPD) (mm)(12 months after therapy)
- Bleeding on probing (BOP) (%)(12 months after therapy)
- Suppuration on probing (SUP) (%)(12 months after therapy)
- Oral health impact profile (OHIP-14sp)(12 months after therapy)
- Bone level (BL) changes(12 months after therapy)
- modified Plaque Index (mPI)(12 months after therapy)
- modified Bleeding Index (mBI)(12 months after therapy)
- Intrabony defect (ID) changes(12 months after therapy)
- VAS Score(12 months after therapy)
研究者
Ramón Pons Calabuig
Dentistry, Master in Periodontics and Implants
Universitat Internacional de Catalunya
研究点 (2)
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