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临床试验/NCT06060119
NCT06060119尚未招募2 期

Comparison of Microneedling With Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial

Krishnadevaraya College of Dental Sciences & Hospital0 个研究点目标入组 12 人开始时间: 2023年11月28日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
12
主要终点
OBJECTIVES OF THE STUDY: The primary outcomes measured will be : 1) Increase in gingival augmentation with microneedling

研究概览

简要总结

The presence study is toComparison of Microneedling with Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

详细描述

The periodontal phenotype previously called as biotype is a reflection of gingiva and buccal bone thickness. It is a vital clinical parameter as it will determine whether there will be recession , dehiscence and fenestration or pocket formation.1Basically gingival epithelium provides a physical barrier to infection and protects the deeper structures thus, the gingival phenotype has major impact on the outcome of the restorative, regenerative, implant and orthodontic therapy.2 Common causes of recession are faulty toothbrushing ,tooth malposition, abnormal frenum attachment, trauma from occlusion and orthodontic tooth movement in labial direction.2 Gingiva can be classified as thick > 1mm and thin < 1mm according to recent 2017 world work shop classification.3 Traditionally, gingival augmentation is achieved using free gingival graft, connective tissue graft, soft tissue substitutes. Subepithelial connective tissue auto graft is still the gold standard. All of these technique's are invasive, complicated, technique senstive and do not have cost efficiency4, thus there is an on going reasearch for a more simpler non invasive method to increase gingival thickness.

Microneedling also knows as "percutaneous collagen induction therapy" is a novel and innovative method to thicken gingiva.5It involves creating several microinjuries in the form of inducing superficial bleeding points there by inducing a wound healing cascade which releases a few key soft tissue growth factor's such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors.1 Fernandes has developed a percutaneous technology based on principals of microneedling to initiate natural post traumatic inflammatory reaction by using microneedles.6 The growthfactor's thus released post injury stimulate proliferation of new cells and transformation of fibroblast into collagen and elastin fiber, starting from 5th day up to 8th week. Newly formed fibers thicken the tissue during the process known as neocollagenesis. Fibroblasts also trigger neoangiogenesis by accelerating the proliferation of endothelial cells in the blood vessels. The tissue remodeling changes continue from 8 weeks up to 1 year.7 Thus, this non-invasive technique of microneedling will be compared to the time tested subepithelial connective tissue autograft to obtain a deeper insight over its feasibility.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years of age.
  • Patients with esthetic concern .
  • Patient under going orthodontic, prosthodontic, restorative treatment where thick gingiva is necessary.
  • Systemically healthy subjects
  • Full mouth plaque index,full mouth bleeding on probing score < or = 15
  • Patient with palatal mucosa greater than 4mm

排除标准

  • Previous periodontal surgery
  • Patients with history of coagulation disorder
  • Smoking habit
  • Pregnant and lactating females
  • Use of any

结局指标

主要结局

OBJECTIVES OF THE STUDY: The primary outcomes measured will be : 1) Increase in gingival augmentation with microneedling

时间窗: 6 months

1. Increase in gingival augmentation with microneedling will be measured in (mm) 2. Comparison of microneedling with subepithelial connective tissue graft for gingival thickness in(mm) digital calliper and spreader file

次要结局

  • thickness in mm(6 months)

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Prabhuji MLV

HOD OF PERIODONTOLOGY

Krishnadevaraya College of Dental Sciences & Hospital

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