Influence of Supracrestal Soft Tissue on Peri-implant Bone Changes for Different Abutment Shapes and Heights: A Four-Arm Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 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 goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. concave abutment) on changes in the marginal bone level (bone loss and bone remodeling) in healthy, partially edentulous volunteer patients undergoing implant-supported rehabilitation.
The main questions it aims to answer are:
- Is there any difference in marginal bone loss for different abutment shapes and heights?
- Do the shape and height of the abutment affect implant success?
All participants will receive bone-level dental implants placed approximately 2-mm below the bone crest, each receiving a different type of abutment and researchers will see whether the shape and height of the abutment influence the success of the implant, periodontal probing depth (PPD), and bleeding on probing (BoP) comparing four groups of patients:
- 2-mm high abutments with cylindrical shape.
- 2-mm high abutments with concave shape.
- 3-mm high abutments with cylindrical shape.
- 3-mm high abutments with concave shape.
Clinical and radiographic assessments will be performed at abutment placement, at definitive prosthesis placement, and at 1, 3, 6, and 12 months after loading to measure marginal bone loss and peri-implant parameters.
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
- •Adults aged 18 years or older.
- •Posterior edentulism (premolars/molars).
- •Good general and oral health, with controlled plaque and bleeding indices.
- •Sufficient bone height and width for implant placement without the need for bone regeneration procedures. Patients who require indirect sinus lift procedure simultaneously with implant placement may be included in the study.
- •Presence of at least 2 mm of keratinized mucosa around the dental implant.
- •Stable occlusion and healthy periodontium.
- •Insertion torque ≥ 35 Ncm at the time of implant placement.
- •Willingness to comply with study protocol and attend scheduled follow-up visits.
排除标准
- •Presence of medical conditions that contraindicate implant surgery, such as heavy smoking (>10 cigarettes per day), severe bruxism, pregnancy or breastfeeding, bisphosphonate therapy, and patients undergoing chemotherapy or radiotherapy in the head and/or neck area.
- •Active periodontal disease or peri-implant infection.
- •Uncooperative patients or patients unable to complete follow- up.
- •Implant failures.
研究组 & 干预措施
3-mm high abutment with concave shape
Participants in this group will receive a 3-mm high abutment with concave shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol.
干预措施: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol (Procedure)
2-mm high abutment with cylindrical shape
Participants in this group will receive a 2-mm high abutment with cylindrical shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol.
干预措施: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol (Procedure)
2-mm high abutment with concave shape
Participants in this group will receive a 2-mm high abutment with concave shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol.
干预措施: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol (Procedure)
3-mm high abutment with cylindrical shape
Participants in this group will receive a 3-mm high abutment with cylindrical shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol.
干预措施: Bone-Level 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]), 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) 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)(3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.)
- Bleeding on probing (presence/absence)(3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 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