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临床试验/NCT04195737
NCT04195737已完成不适用

Comparative Evaluation of Coronally Advanced Root Coverage Procedure With Ossix Volumax™ Collagen Matrix and Connective Tissue Graft-Randomized Controlled Trial

Krishnadevaraya College of Dental Sciences & Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
gingival recession depth

研究概览

简要总结

The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a coronally advanced flap with ossix volumaxTM collagen matrix and connective tissue graft in the treatment of multiple adjacent gingival recession defects.

The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

详细描述

Periodontal plastic surgery are surgical procedures performed to prevent or correct anatomic, developmental, traumatic or disease-induced defects of the gingiva, alveolar mucosa or bone. It includes various soft and hard tissue procedures aimed at gingival augmentation, root coverage, correction of mucosal defects at implants, crown lengthening, gingival preservation at ectopic tooth eruption, removal of aberrant frena, prevention of ridge collapse associated with tooth extraction and augmentation of the edentulous ridge.1

Different predisposing anatomic features can result in recession such as position and anatomy of teeth in the dental arch, bony dehiscence, thickness of the alveolar mucosa, muscle pull, orthodontic treatment, thin gingival biotype, buccal prominence of teeth, lack of keratinized tissue, abnormal frenum attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation.2 The migration of the marginal tissue to an apical position may lead to esthetic concern, dentin hypersensitivity, root caries, and cervical wear. Treatment modalities for gingival recession have many influencing factors such as defect dimensions (depth, width), site (maxilla, mandible), defect number (single, multiple), soft tissue anatomy (keratinized tissue quality/quantity; papilla height/width; frenum/ muscle pull; vestibular depth) tooth position etc.

Various surgical techniques for the treatment of recessions includes the use of full or partial thickness flap with various soft tissue grafts such as epithelized free gingival grafts (FGG) or sub-epithelial connective tissue graft (SCTG) in conjunction with various types of flaps eg: (envelope, coronally or laterally positioned flap, double pedicle flap (DPF) or tunnelling (TUN) alone or combined with laterally positioned pedicle flaps (LPPF).3 Coronally advanced flap (CAF) with connective tissue graft (CTG) is considered as the gold standard treatment for gingival recession. Commercially available materials for root coverage are expanded Poly Tetra Fluoro Ethylene (Gore-Tex), polglactin, Collagen membranes like biogide, biomend, resolute, alloderm, collatape etc, collagen matrix such as mucograft, human amniotic membrane, dermagraft, ossix.4

Recently in a case report using platelet concentrate carried on collagen sponge (ossix) showed favourable results.4 Ossix volumax™ has shown De novo bone formation when used in alveolar ridge augmentation procedure.5

Ossix volumax™ (Datum dental) is one such recently identified sugar cross-linked bio programmed collagen matrix. Ossix volumax™ is a volumizing, thick collagen scaffold, featuring glymatrix technology. The properties are thick and expand when wet, excellent handling, easy to use, adapts and adheres to the bone.5 It undergoes rapid ossification (in CT scans and histology after one month).6

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 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to18 years.
  • Multiple adjacent Miller's class I and class II gingival recession sites.
  • Patients with healthy or treated periodontal conditions.
  • Patients with esthetic concerns.
  • Absence of uncontrolled medical conditions.
  • Full mouth plaque score </= 10% (O'Leary 1972)
  • Full mouth bleeding score <10% (Ainamo and Bay 1975)

排除标准

  • Gingival biotype less than 0.8 mm.
  • Pregnant or lactating females.
  • Tobacco smoking.
  • Untreated periodontal conditions.
  • Use of systemic antibiotics in the past 3 months.
  • Patients treated with any medication known to cause gingival hyperplasia

结局指标

主要结局

gingival recession depth

时间窗: 6 months

measured as the distance from the CEJ to the gingival margin.

Complete root coverage

时间窗: 6 months

root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction

Mean root coverage

时间窗: 6 months

(Baseline recession depth - 6 month recession depth/Baseline recession depth)\*100

次要结局

  • Gingival Recession width(6 months)
  • Plaque index(6 months)
  • pocket Probing depth(6 months)
  • Clinical attachment level(6 months)
  • Apico-coronal width of keratinized tissue(6 months)
  • Root coverage esthetic score(6 months)
  • Gingival index(6 months)
  • Gingival biotype thickness(6 months)
  • Gingival Bleeding index(6 months)

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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