Influence of Implant Placement Depth (-2 mm vs -4 mm Subcrestal) on Peri-implant Tissue Conditions: a Randomized Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in peri-implant marginal bone level (mm)
研究概览
简要总结
The primary aim of this randomized clinical trial is to evaluate the influence of subcrestal implant placement depth (-2 mm vs -4 mm) on peri-implant marginal bone level changes, including marginal bone loss and bone remodeling. Secondary outcomes include implant success, peri-implant probing depth (PPD), and bleeding on probing (BoP).
Partially edentulous patients requiring fixed implant-supported prosthetic rehabilitation with two implants in posterior maxillary or mandibular regions will be included. Implants will be placed subcrestally at either -2 mm or -4 mm from the bone crest, following a submerged healing protocol. Allocation to insertion depth will be randomized. Marginal bone level changes will be assessed using standardized periapical radiographs at second-stage surgery, prosthesis placement, and at 1, 3, 6, and 12 months after functional loading. PPD and BoP will be recorded at the same time points.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥18 years old with partial edentulism.
- •Need for rehabilitation with fixed implant-supported prostheses in posterior regions.
- •Availability of minimum bone height for implants ≥6 mm in length.
- •Minimum bone width without the need for guided bone regeneration.
- •Supracrestal soft tissue thickness ≥2 mm.
- •Non-smokers or smokers of ≤10 cigarettes/day.
- •Plaque index and bleeding on probing <20%.
- •Probing depth ≤3 mm.
- •Signed informed consent.
排除标准
- •Systemic diseases contraindicating implant surgery.
- •Treatment with intravenous bisphosphonates.
- •Head and neck radiotherapy.
- •Uncontrolled diabetes.
- •Pregnancy or breastfeeding.
- •Alcohol or drug use.
- •Psychiatric disorders.
- •Need for bone regeneration procedures.
- •Inability to complete follow-up.
- •Implant failure during the study period.
研究组 & 干预措施
-2 mm subcrestal implant placement with 2-mm slim transmucosal abutments
Participants in this group will receive implants placed 2 mm below the level of the alveolar bone crest. Implants will share the same design, surface characteristics, and prosthetic connection, including platform switching. Slim transmucosal abutments with a height of 2-mm will be placed according to the subcrestal depth to ensure an adequate transmucosal profile and a stable relationship between the implant, peri-implant soft tissues, and the prosthetic restoration
干预措施: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol (Procedure)
-2 mm subcrestal implant placement with 3-mm slim transmucosal abutments
Participants in this group will receive implants placed 2 mm below the level of the alveolar bone crest. Implants will share the same design, surface characteristics, and prosthetic connection, including platform switching. Slim transmucosal abutments with a height of 3-mm will be placed according to the subcrestal depth to ensure an adequate transmucosal profile and a stable relationship between the implant, peri-implant soft tissues, and the prosthetic restoration.
干预措施: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol (Procedure)
-4 mm subcrestal implant placement with 4-mm slim transmucosal abutments
Participants in this group will receive implants placed 4 mm below the level of the alveolar bone crest. Implants will share the same design, surface characteristics, and prosthetic connection, including platform switching. Slim transmucosal abutments with a height of 4-mm will be placed according to the subcrestal depth to ensure an adequate transmucosal profile and a stable relationship between the implant, peri-implant soft tissues, and the prosthetic restoration.
干预措施: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol (Procedure)
-4 mm subcrestal implant placement with 5-mm slim transmucosal abutments
Participants in this group will receive implants placed 4 mm below the level of the alveolar bone crest. Implants will share the same design, surface characteristics, and prosthetic connection, including platform switching. Slim transmucosal abutments with a height of 5-mm will be placed according to the subcrestal depth to ensure an adequate transmucosal profile and a stable relationship between the implant, peri-implant soft tissues, and the prosthetic restoration.
干预措施: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol (Procedure)
结局指标
主要结局
Changes in peri-implant marginal bone level (mm)
时间窗: From abutment placement (baseline time [TB]), 1 month post (T1), and at 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) months after definitive prosthesis placement.
Parallelized periapical radiographs will be obtained and a calibrated digital tool will be used to determine the vertical distance from the implant-abutment junction to the most coronal bone-to-implant contact on the mesial and distal sides. Unit of measure: Milimeters (mm)
次要结局
- Peri-implant probing depth (mm)(1 month post-op (T1), and at months 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) after definitive prosthesis placement.)
- Bleeding on probing (presence/absence)(1 month post-op (T1), and at months 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) after definitive prosthesis placement.)
- Implant success(From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.)
研究者
Juan Carlos Bernabeu Mira
Professor, PhD
University of Valencia