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临床试验/NCT04198376
NCT04198376已完成不适用

The Laterally Closed Tunnel Versus Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft for Treatment of Deep Isolated Mandibular Anterior Gingival Recession Defects: A Randomized Controlled Clinical Trial

Krishnadevaraya College of Dental Sciences & Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Gingival Recession Depth (RD)

研究概览

简要总结

The aim of this study is to comparatively evaluate the advantages of LCT with SCTG over MCAT with SCTG for coverage of deep isolated mandibular anterior recession.

详细描述

Gingival recession is defined as the displacement of the soft tissue margin apical to the cementoenamel junction.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, high frenum attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation.

It is a common finding in patient with a high standard of oral hygiene as well as in periodontally untreated populations with poor oral hygiene.The migration of the marginal tissue to an apical position may lead to esthetic concern, dentin hypersensitivity, root caries, and cervical wear.

Mandibular gingival recession defects present significant therapeutic challenges such as shallow vestibular depth, high frenal attachment, thin soft tissue biotypes leading to thin coronally advanced flaps, and thin often dehisced labial bone.Due to these factors the mandibular sites suffers strong and constant tension in comparison to the maxilla, hence there is lack of predictability in the mandibular sites.

Various surgical techniques have been proposed for the treatment of isolated mandibular recessions including the use of fully or partially epithelized free gingival grafts (FGG) or sub epithelial connective tissue graft 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).

Coronally advanced flap (CAF) +connective tissue graft (CTG) is considered as the gold standard treatment in reducing or eliminating gingival recession. Tunnel technique was first introduced by Allen in 19949, and its modifications by Zabalegui in 199910, Modified Coronally Advanced Tunnel (MCAT) by Azzi et al 2002 and Microsurgical CAT by Zuhr 2007.

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
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Isolated Miller's class I, II, III or combined recession defects in mandibular arch.
  • •Age >/= 18 years.
  • •Patients with healthy or treated periodontal conditions.
  • •Patients willing to participate in the study.
  • •Absence of uncontrolled medical conditions.
  • •Full mouth plaque score </= 10%(O'Leary 1972).
  • •Full mouth bleeding score <10%(Ainamo and Bay 1975).
  • •Patients with esthetic concerns.

排除标准

  • •Pregnant or lactating females.
  • •Tobacco smoking.
  • •Uncontrolled medical conditions.
  • •Untreated periodontal conditions.
  • •Use of systemic antibiotics in the past 3 months.
  • •Patients treated with any medication known to cause gingival hyperplasia.
  • •Drug and alcohol abuse.
  • •No occlusal interferences.

研究组 & 干预措施

The Laterally Closed Tunnel Technique with SCTG

Experimental

Following the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes. Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures

干预措施: Group A The Laterally Closed Tunnel Technique with SCTG (Procedure)

Modified Coronally Advanced Tunnel Technique with SCTG.

Experimental

In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator .A second surgical site will be prepared to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site. After sutures are slid through each tunnelled interdental area the needle will be pushed through the CTG before it is guided back through the undermined tissues.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingival papillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization.

干预措施: Group B Modified Coronally Advanced Tunnel Technique with SCTG. (Procedure)

结局指标

主要结局

Gingival Recession Depth (RD)

时间窗: 6 Months

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

次要结局

  • Mean Root Coverage (MRC)(6 Months)
  • Apico-coronal Width of Keratinized Tissue (KTW)(6 Months)
  • Gingival Biotype Thickness(6 Months)
  • Gingival Recession Width(6 Months)
  • Pocket Probing Depth(6 Months)
  • Complete Root Coverage (CRC).(6 Months)
  • Root coverage Esthetic Score (RES)(6 Months)
  • Clinical Attachment Level(6 Months)
  • Plaque Index (PI)(6 Months)
  • Gingival Index (GI)(6 Months)
  • Bleeding Index (BI)(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 (1)

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