Ten-Year Follow-Up Analysis of MBL and PES Outcomes Around Convergent Transmucosal Profile Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Marginal bone level
研究概览
简要总结
The aim of the study is to evaluate the marginal bone level (MBL) and pink aesthetic score (PES) changes on the short, medium and long-term, on a retrospective cohort of patients who received at least one "biotype implant" (DEI ITALIA SRL, Mercallo VA, Italy) with convergent transmucosal profile. Ninety-seven patients with at least one periapical x-ray taken on the day of implant placement and at least one taken in the following 10 years were included for MBL analysis and 90 patients who had at least one photograph taken on the day of implant loading, and one taken in the following 10 years for PES analysis. The radiographs were divided into 4 groups: (1) implant placement; (2) 1-2 years follow-up (short-term); (3) 3-6 years follow-up (medium-term); (4) ≥7 years follow-up (long-term). Photographs were grouped similarly, except that the first group was relative to the day of prosthetic loading. MBL was measured using ImageJ software. Results were analyzed with Generalized Estimating Equations method using SPSS software, the P value was set at <0.05 for significance.
详细描述
Modern implantology has evolved over the past decades toward solutions that optimize not only the **functional stability** of implants but also the **aesthetic outcome** and the preservation of **hard and soft tissues**. One such innovation is the *convergent transmucosal profile*, a design configuration for dental implants aimed at promoting the coronal migration of collagen fibers, reducing **marginal bone loss (MBL)**, and improving the stability of soft tissues.
**Marginal Bone Loss (MBL)** is a key parameter in assessing the long-term stability of implants and is measured as a reduction in the height of the marginal bone around the implant. The **Pink Esthetic Score (PES)**, on the other hand, qualitatively evaluates the aesthetic outcome of the peri-implant soft tissues by considering parameters such as the shape and fullness of the papilla, the contour of the soft tissues, and the color of the mucosa in relation to the prosthesis.
This **retrospective study** aims to evaluate, in a cohort of patients, the effectiveness of the convergent transmucosal profile of dental implants with respect to bone stability and aesthetic outcomes.
**Study Aim** The main objective of the study is to analyze the **long-term stability** of Marginal Bone Level (MBL) and the Pink Esthetic Score (PES) in a retrospective cohort of patients treated with implants featuring a convergent transmucosal profile. The study intends to identify correlations between aesthetic parameters and bone stability, also evaluating the clinical implications of this implant design.
**Materials and Methods**
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients aged between 18 and 75 years.
- •Presence of at least one periapical radiograph taken at the time of implant placement and another at 1-2 years, 3-6 years, and 7-10 years after insertion.
- •Photographic documentation for PES assessments performed at prosthetic loading and during follow-ups.
排除标准
- •Patients with uncompensated systemic diseases (uncontrolled diabetes, severe autoimmune diseases).
- •Heavy smokers (>10 cigarettes per day).
- •Incomplete clinical and radiographic documentation.
结局指标
主要结局
Marginal bone level
时间窗: 1 to 10 years after implant placement compared to baseline
The level of the peri-implant marginal bone measured on intraoral radiograph at various time points
Pink Esthetic Score
时间窗: from baseline (implant placement) to 10 years
A scoring system that evaluates the esthetic appearance of soft tissue around dental implants based on five parameters-mesial papilla, distal papilla, curvature and level of facial mucosa, and root convexity/soft-tissue color and texture-each scored from 0 to 2, for a maximum of 10 points
次要结局
未报告次要终点
研究者
Nicola Alberto Valente, DDS, MS, PhD
Associate Professor
University of Cagliari