CTRI/2024/05/067607尚未招募2/3 期
Comparison of Soft and Hard Tissue Changes Around Dental Implants with Xenogenic Collagen and Connective Tissue Grafts Using Intraoral Scanner and Radiographs: Randomized Controlled Trial.
Dr. Sejal Satish Mali1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年5月31日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Evaluation of soft tissue thickness and surface area around implants.
研究概览
简要总结
| Implant dentistry has become an integral part of modern dentistry and its success is no longer determined merely by osseointegration.There is a paradigm shift in dental implantology with an increased importance placed on the quality and quantity of soft tissues around dental implants to improve the surgical, esthetic and prosthetic outcomes of the implant therapy. |
| Albrektsson |
| recently coined this as a new concept |
| called ‘mucointegration’ which means dense soft tissue contact with an |
| abutment that can act as a barrier to protect the underlying bone and is the |
| basis for long term tissue health and stability. Long |
| term peri-implant soft tissue stability is affected by the peri-implant tissue |
| phenotype. The term encompasses the three-dimensional gingival volume and |
| thickness. Thin phenotype predisposes the tissues to |
| attachment loss. They are at a higher risk of esthetic complications in the |
| long term like mid-facial peri-implant mucosal recession, incomplete papilla |
| fill and decreased soft tissue stability which may lead to implant failure. Crestal |
| bone loss has been linked to thinner gingival phenotypes as the thick gingival |
| phenotypes are less prone to buccal changes. Adequate amount of soft tissue is |
| needed to curb the crestal bone loss & achieve biologic width of the peri-implant mucosa. Various |
| methods have been proposed for obtaining adequate amounts of gingival soft |
| tissue thickness depending on the technique and patients need. These can be |
| performed before implant placement, at the time of implant placement or at the |
| time of second stage implant surgery. Apically positioned flaps, laterally |
| positioned flaps, free gingival grafts or connective tissue grafts are some of |
| the most commonly used methods for increasing the zone of soft tissue thickness around implants. Current |
| scientific data recommends the use of autogenous connective tissue grafts (CTG) as the |
| grafting material of choice for increasing the soft tissue thickness and |
| improving the esthetics around dental implant sites. But the CTG is inevitably |
| accompanied by increased morbidity as it requires an additional harvesting |
| procedure. To overcome the drawbacks of the autogenous |
| grafts many alternative materials such as xenogenic collagen scaffold have been developed. The fundamental issue is to choose the material |
| which will assure the maximum therapeutic effect while minimizing the negative |
| influence on the patient’s health. The collagen matrix offers mechanical stability associated with good biological behaviour, promotes tissue formmation, angiogenesis & similar outvomes compared to gold standard in terms of volume increase. Periodontal |
| probes and endodontic files are commonly used to evaluate soft tissue changes. |
| But these evaluate the changes only |
| in one-dimension. At present, digital methods for evaluating peri-implant soft |
| tissue changes have gradually become an outcome of interest in different |
| literatures possibly because of its noninvasiveness, accuracy, and the digital |
| information could be saved in computer permanently. A recent study summarized |
| the available evidence regarding traditional and digital methods for the |
| evaluation of peri-implant soft tissue changes and concluded that traditional |
| methods can’t show the entire changes while digital methods can. The |
| digital scanned files obtained by an intraoral scanner can be converted into |
| Standard Tessellation Language (STL) file formats. These |
| files are transferred to a three dimensional analysis software where they are |
| superimposed and evaluation of the change in thickness can be done. There |
| are limited studies involving the use of digital methods for the evaluation of |
| peri-implant soft tissue changes. Thus the aim of the study is to compare the |
| soft and hard tissue changes around dental implants at stage II implant surgery |
| with xenogenic collagen scaffold and connective tissue graft using intraoral |
| digital scanner and radiographs. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with age of 18-60 years.
- •Patient who had undergone dental implant stage I surgery.
- •Patient with thin gingival phenotype.
- •Adequate oral hygiene.
排除标准
- •Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
- •Patients with thick gingival phenotype around implants.
- •Patients with implant sites that presented complications.
- •Patients who are not willing for the xenogenic graft which is of porcine origin.
- •Pregnant or lactating females.
- •Patients not willing to participate in the study.
结局指标
主要结局
Evaluation of soft tissue thickness and surface area around implants.
时间窗: Evaluation of soft tissue thickness will be done at baseline and after 90 days and surface area around implants will be evaluated after 90 days.
次要结局
- Crestal bone loss(Crestal bone loss will be evaluated at baseline & 90 days after stage II implant surgery.)
研究者
Dr Sejal Satish Mali
Government Dental College and Hospital Nagpur
研究点 (1)
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