A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile and Evaluation of Peri-implant Soft Tissue; an In-vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gingival Index (GI)
研究概览
简要总结
The study focuses on the critical role of the gingival emergence profile in the success of dental implants, emphasizing its importance for both peri-implant health and esthetics. The research aims to evaluate and compare the effectiveness of two common, cost-effective dental materials-light-cure composite and Protemp (a bis-acryl composite resin)-for fabricating customized healing abutments. By assessing the peri-implant tissue response to these materials, the study seeks to determine which is more suitable for creating an optimal, natural-looking soft tissue contour, thereby providing dentists with a practical and reliable alternative to more expensive options like PEEK.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years.
- •Edentulous spaces to be replaced with implant-supported single crowns.
- •Antagonistic natural tooth present and sound (sound periodontium) (Stable occlusion and opposing dentition)
- •Good general periodontal health
- •Good general health.
- •Willing to participate in the study and able to sign informed consent. (Ability to attend all follow-up appointments.)
排除标准
- •Untreated caries or periapical lesions in the opposing natural antagonistic tooth.
- •Active periodontal disease.
- •major active systemic disease affecting soft tissue healing
- •Multiple implant supported restorations already present.
- •Long edentulous spaces.
- •Complete edentulous cases
研究组 & 干预措施
customized healing abutment - bulk-fill flowable composite
干预措施: Customized Healing Abutment - bulk fill composite (Procedure)
standard titanium healing abutment
standard titanium healing abutments used
customized healing abutment - Protemp 4 (Bis-Acryl composite)
干预措施: customized healing abutments - Bis acryl composite materials (Procedure)
结局指标
主要结局
Gingival Index (GI)
时间窗: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Gingival Index (GI): This index is used to evaluate inflammation of the gums around the implant. Scale: 0 to 3. Interpretation: A higher score indicates a worse outcome, signifying greater gingival inflammation.
Probing depth (PI)
时间窗: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Probing Depth (PD): This is a direct clinical measurement, not a scored scale, taken in millimeters at six points around the implant. Interpretation: Deeper measurements are generally associated with less healthy peri-implant tissue. Therefore, a lower value indicates a better clinical outcome.
Pain Numeric Scale
时间窗: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Pain Numeric Rating Scale (NRS): This scale measures the patient's subjective experience of pain during the insertion of the final prosthesis. Scale: 0 ("no pain") to 10 ("worst pain imaginable"). Interpretation: A higher score indicates a worse outcome, representing more severe pain.
Pink Esthetic Score (PES)
时间窗: T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.
Pink Esthetic Score (PES): This score is used to assess the aesthetic quality of the soft tissue surrounding the implant restoration. Scale: 0 to 14. Interpretation: A higher score indicates a better and more aesthetically pleasing outcome.
次要结局
- Plaque Index (PI)(T2: At the one-month follow-up appointment.)
研究者
Bhavin Milind Patil
Principal Investigator
Amrita Institute of Medical Sciences & Research Center