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临床试验/CTRI/2024/05/067558
CTRI/2024/05/067558已完成4 期

Comparative evaluation of efficacy of tunneled coronally advanced flap versus coronally advanced flap with collagen matrix for management of isolated gingival recession: A randomized clinical trial

Army Dental Centre RR1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Reduction in gingival recession height

研究概览

简要总结

Gingival recession (GR) is defined as the exposure of the root surface due to apical migration of junctional epithelium apical to the cementoenamel junction (CEJ). GR is usually associated with dentinal hypersensitivity, susceptibility to root caries, and aesthetic concern. Therefore, obtaining root coverage (RC) becomes an integral part in the treatment of GR. Hence, the goal of root coverage is to restore the gingival structure functionally and esthetically.

Several surgical treatment modalities, such as free gingival autograft, free connective tissue autograft, pedicle autografts, laterally positioned pedicle flap, coronally advanced flap (CAF), subepithelial connective graft, guided tissue regeneration and pouch and tunnel technique have been used for gingival recession treatment.

Coronally advanced flap (CAF) with connective tissue graft (CTG) remains the gold standard till date. One of the recent technique is Tunneled coronally advanced flap (TCAF) which minimizes incisions and reflection of flaps and provide abundant blood supply and intimate contact of the donor tissue with the recipient site.

The efficacy of the tunnel technique with a CTG from the tuberosity for the treatment of multiple gingival recession has been investigated. The rationale behind using TCAF relies on the fact that the Tunnel technique can detach the buccal papillae from the interproximal bone, allowing for a coronal repositioning of the midfacial soft tissues.

Several soft tissue substitutes have been utilized as alternatives to CTG to avoid increased post-operative morbidity due to second surgical site. Collagen matrix (CM) was employed to treat recession deformities without the discomfort of second surgical sites, as was the case with CTGs. CM possesses hemostatic qualities, biocompatible and function as a scaffold for fibroblasts and promote tissue remodeling. When combined with tissue augmentation techniques, the CM has demonstrated the ability to increase the width of keratinized tissue surrounding teeth.

Gain in the root coverage is an advantage of the CAF at the papilla without attachment loss and tunneling minimizes the incisions and flap reflection thereby providing abundant blood supply to the tissues and intimate contact with recipient site. Therefore to take advantage of both coronally advanced flap and tunneling simultaneously, TCAF was introduced. TCAF is a recent novel technique and has not been compared with coronally advanced flap (the gold standard technique).

The aim of this study is to compare the effectiveness of tunneled coronally advanced flap (TCAF) versus coronally advanced flap (CAF) with collagen matrix (CM) for the management of isolated Cairo’s recession type 1 gingival recession.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • a) Patients aged between
  • 40 years. b) Patients with isolated Cairo’s RT1 GR located on anteriors and premolar teeth. c) Patients with ASA 1 physical status classification. d) No surgical periodontal therapy in last 2 years at the involved site e) Teeth having clinically identifiable CEJ.

排除标准

  • a) Teeth having root caries / non-carious cervical lesions (NCCL) or previous restoration.
  • b) Past or current tobacco users (both smoking and chewing tobacco).
  • c) Pregnant/Expecting/Lactating women.
  • d) Full mouth bleeding score (FMBS) & Full mouth plaque score (FMPS) ≥ 10% after completion of Phase I therapy.
  • e) Patients with a history of known allergy to xenogenic biomaterials.

结局指标

主要结局

Reduction in gingival recession height

时间窗: At 3 months and 6 months

次要结局

  • Reduction in gingival recession width(At 3 months and 6 months)
  • Increase in width of keratinized gingiva(At 3 months and 6 months)
  • Gain in clinical attachment level(At 3 months and 6 months)
  • Modified gingival bleeding index(At 3 months and 6 months)
  • Complete root coverage(At 3 months and 6 months)
  • Mean root coverage(At 3 months and 6 months)

研究者

发起方
Army Dental Centre RR
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Col T Prasanth

Army Dental Centre R R

研究点 (1)

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