Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment: A Randomized Controlled Clinical Study With Biochemical Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pink Esthetic Score
研究概览
简要总结
The goal of this clinical trial is to learn if using zirconia-based composite customized healing abutment can have a favorable effect on peri implant soft tissue that may be related to the superior biological properties of zirconium nano particles regarding increased biocompatibility and decreased inflammatory response Patients that are eligible for implant placement
The main question it aims to answer is:
Does zirconia-based composite customized healing abutment have a significantly different effect on peri-implant soft tissue compared to conventional composite customized healing abutment in terms of biological properties or biocompatibility or inflammatory response? Researchers will compare between direct zirconia-based composite customized healing abutments vs conventional composite customized healing abutments placed simultaneously with delayed dental implant placement.
Participants will be undergo the following procedures :
A) Presurgical procedures:
- Detailed clinical examination, full history, and radiographic examination (CBCT) will be performed initially to aid in patients' selection.
- After enrollment, all participants will sign the informed consent.
- All participants will be subjected to periodontal phase I treatment including periodontal supra- and sub-gingival debridement and oral hygiene instructions.
B) Surgical procedures:
- After local anesthesia administration, flap is raised, osteotomy site preparation, and implant will be placed.
- Check the ISQ to exceed or equal 70 unit.
- A customized Light-cured Direct Zirconia-Based Composite or A customized Light-cured Direct Convential Composite Healing Abutment will be placed.
Then all participants should follow up at the following times : Baseline, 1,2 and 3 months after implantation.
详细描述
Light-cured direct zirconia-based composite has many potential uses in dentistry, because of mechanical and biological reasons maintaining the health of peri-implant soft tissues during healing.
Direct zirconia-based composite customized healing abutments have superior properties such as biocompatibility, chemical stability, antibacterial and mechanical properties.
Aim of the study: This study will be carried out to compare zirconia-based composite customized healing abutments vs conventional composite customized healing abutment placed simultaneously with delayed dental implant placement.
Materials and Methods: This will be done by clinical evaluation of peri-implant soft tissue changes. Moreover, peri-implant sulcus fluid (PISF) will be measured for the level of Interleukin-1 beta (IL-1β) in the gingival crevicular fluid.
PICOTS Elements:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire (Pendleton et al., 2004).
- •Both genders.
- •Age from 20-50 years.
- •Missing tooth to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures (Beretta et al., 2019).
- •Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor (Baltayan et al., 2016).
- •Sound Mesial and distal neighboring teeth.
- •At least 6 natural teeth remaining in the same arch .
- •Mouth opening ≥ 30mm.
- •Thick phenotype.
排除标准
- •Poor oral hygiene condition.
- •Pregnant and lactating females.
- •Vulnerable groups (Prisoners and handicaps).
研究组 & 干预措施
Zirconia-based composite customized healing abutment
Participants in this arm will receive a customized healing abutment made of Zirconia-based composite material fabricated chairside.
The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing.
The abutment is placed immediately after implant placement and will remain in place for 3 months.
干预措施: Zirconia-based composite customized healing abutment (Other)
Conventional composite customized healing abutment
Participants in this arm will receive a customized healing abutment made of conventional composite material fabricated chairside.
The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing.
The abutment is placed immediately after implant placement and will remain in place for 3 months.
干预措施: Conventional composite customized healing abutment. (Other)
结局指标
主要结局
Pink Esthetic Score
时间窗: Baseline, 1,2 and 3 months after implantation.
The Pink Esthetic Score is used to evaluate the soft tissue esthetics around single-tooth implants. It includes 7 parameters: mesial and distal papilla, tissue contours, gingival level, alveolar process, and both the color and texture of the soft tissue. Each is scored from 0 to 2, with higher scores reflecting more natural esthetics. For the papillae, a score of 0 indicates the papilla is missing, 1 is incomplete, and 2 is complete. Tissue contours are rated as unnatural (0), virtually natural (1), or natural (2). Gingival level is assessed based on vertical discrepancy with adjacent teeth: more than 2 mm scores 0, 1-2 mm scores 1, and less than 1 mm scores 2. The alveolar process is scored as clearly resorbed (0), slightly resorbed (1), or showing no difference (2). Finally, both soft tissue color and texture are evaluated against the neighboring tissue: a clear difference (0), a slight difference (1),no difference (2). The maximum PES is 14, represents ideal soft tissue esthetics.
Papilla index
时间窗: baseline, 1,2 and 3 months
The Papilla Index is a clinical tool used to evaluate the degree of interdental papilla fill in the proximal space around implants. It is scored on a scale from 0 to 4. A score of 0 indicates that no papilla is present. A score of 1 means less than half of the papilla height is visible. A score of 2 is assigned when half or more of the papilla height is present, though not completely filling the space. A score of 3 denotes a papilla that fully occupies the entire proximal space, representing the ideal scenario. A score of 4 indicates a hyperplastic papilla, where the tissue extends beyond the normal contours.
次要结局
- Biochemical assessment of IL-1β level in the gingival crevicular fluid(After 2 months of implant placement)
研究者
ahmed asem elsayed abd elmoteleb
Principal Investigator
Ain Shams University