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临床试验/NCT06853704
NCT06853704已完成2 期

The Clinical Effects of Using Collagen Matrix in Papilla Augmentation: a Prospective Clinical Trial.

King Abdullah University Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年6月15日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
8
试验地点
1
主要终点
papilla height

研究概览

简要总结

Black triangles, also known as open gingival embrasures, are usually the result of the lack of papilla fill interdentally. With the improvement of dental procedures and materials, more attention has been directed to improving this unesthetic occurrence. Improvement of papilla loss (black triangle) can be mainly categorized into non-surgical and surgical techniques with most surgical modalities focused on a minimally invasive approach due to the restricted working area and blood supply to the papilla. Collagen matrix offers strong mechanical properties while promoting tissue healing and hence is used in many periodontal plastic surgeries (gum surgeries). However, the outcome of collagen matrix in treating papilla loss has not been studied yet. This study aimed to see at the clinical effects of collagen matrix in papilla augmentation using a minimally invasive surgical approach.

Patients with papillae loss were selected and Collagen matrix (Geistlich Fibro-Gide) used to stabilize the affected area with a minimally invasive surgical procedure. Papilla height gain, texture and color will be assessed pre-operatively, three and six months postoperatively. in addition, probing depth, clinical attachment level and keratinized tissue width will also be assessed.

详细描述

Introduction and Hypothesis of the Study:

The focus on achieving highly esthetic dental outcomes has increased nowadays, especially with the improvement of restorative and periodontal surgical techniques. Black triangles, an unesthetic occurrence due to lack of papilla, can occur when there is loss of the periodontal interproximal attachment apparatus. Plaque associated periodontal disease has been the most common reason for black triangle formation. However, it can also be caused by trauma, improper restorations contours, aggressive flossing, spacing between teeth and iatrogenic damage.

Patients with black triangles usually complain from unpleasant esthetic appearance, particularly when it harvests calculus, stains, and food. It usually gets worse with time requiring more attention in cleaning these open gingival embrasures using interdental brushes and floss.

Many surgical and non-surgical treatment modalities have been proposed as possible treatments for papilla loss. The non-surgical approach includes repeated root planning and curettage, and correcting contact points orthodontically to help induce papilla fill. Surgical papilla augmentation remains a challenge in periodontal regeneration due to the restricted interdental space and patterns of blood supply to the area. Many surgical techniques were suggested to overcome these challenges; semilunar incision where the papilla is left untouched, the use of a pedicle flap in a microsurgical technique without releasing incisions and papilla augmentation with customized connective tissue graft using the interproximal tunneling technique .The current literature on surgical correction techniques are mainly comprised of case reports and case series, and no standard surgical treatment of black triangles has been devised yet.

Collagen based matrices (CM) is a bovine-equine collagen-based tissue. Due to its strong mechanical properties, it acts as scaffold material for cell migration and helps in the overall healing process. CM has become very widely used and has proved its superiority in many periodontal procedures due to its excellent tissue color matching.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients above the age of 18 years old with papilla loss.
  • papilla loss between 2 natural teeth.
  • Absence of active periodontal disease.
  • Patients willing to follow oral hygiene measures.
  • At least one papillary recession in the maxilla from UR5 to UL
  • Papillay recession classified as 1 or 2 according to Nordland and Tarnow classification
  • Sites with less than 7 mm measurement from the contact point to the bone crest.
  • Sites having adequate width of attached gingiva(>2mm).

排除标准

  • Patients with incorrect crown or restoration margins, and/or caries.
  • Patients undergoing orthodontic treatment.
  • Patients who consume alchohol/smoking .
  • Papilla loss around dental implant.
  • Patients with any systemic disease that may compromise or affect the results of the surgical procedure.
  • Breast feeding or pregnant woman.

结局指标

主要结局

papilla height

时间窗: 6 months

papilla loss , papilla height reduction , before and after the surgery measuring from contact point to interdental tissue level.

次要结局

  • esthetic score, texture,color,contour(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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