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临床试验/NCT05682274
NCT05682274进行中(未招募)不适用

The Effect of Placement of the Apical Margin of the Restoration in the Treatment of Gingival Recession Associated With Non-carious Cervical Lesion With Combined Restorative and Periodontal Therapy

Gazi University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Change in gingival recession height

研究概览

简要总结

The aim of this randomized, parallel-group clinical trial was to compare the 1-year periodontal, root coverage, esthetic, and patient-centered outcomes of the partial restoration placement with different apical margin levels combined with coronally advanced flap (CAF) plus connective tissue graft (CTG) in the treatment of isolated gingival recessions associated with non-carious cervical lesions (NCCL). Forty patients with single gingival recessions (RT1 gingival recessions and class B+ NCCL) were randomly allocated to either placement of restoration apical margin at the level of estimated cementoenamel junction (CEJ) or within 1 mm apical to the CEJ. Two weeks after the restorative treatment, all recession defects were treated with CAF combined with CTG. Periodontal measurements were taken at baseline, and 3, 6, and 12 months postoperatively. Patient-centered outcomes were evaluated at baseline, and 7, and 15 days, 6, and 12 months postoperative follow-ups. Modified root closure aesthetic score (mRES) was used to assess aesthetics at 6 and 12 months follow-ups.

详细描述

Gingival recessions associated with non-carious cervical lesions (NCCL) involving the CEJ area, which form a combined defect (CD), can lead to complex soft tissue management during periodontal plastic surgeries and result in poor clinical/aesthetic outcomes. Since CD encompasses both hard and soft tissue loss, different periodontal/restorative multidisciplinary protocols have been suggested to treat this challenging situation. Reconstruction of the coronal portion of NCCL with a resin composite filling (partial restoration approach) before the surgical procedure has been suggested to present favorable and predictable outcomes in the treatment of gingival recessions associated with NCCL. For the partial restoration approach, two different protocols to restore the most coronal zone of the NCCL have been proposed according to the extension of the apical margin of the restoration, which are the placements at the level of CEJ or within 1 mm apical to the CEJ. Both approaches have some advantages and disadvantages. After root coverage procedures, if complete closure has been achieved, placing the apical restoration margin at the estimated CEJ level would allow the gingival margin to contact only the root surface and not cover the apical part of the restoration. However, in cases with incomplete root coverage, the placement of the restoration border 1 mm apically of the CEJ could prevent the formation of a gap between the gingival margin and the apical border of the restoration that results in esthetic compromises, and the persistence of dentin hypersensitivity. However, there is no study in the literature comparing these two different locations of the apical border of the restoration in periodontal/restorative combined therapy. Therefore, the aim of this study was to compare the 1-year periodontal, root coverage, esthetic, and patient-centered outcomes of the partial restoration placement with different apical margin levels combined with CAF plus CTG in the treatment of isolated gingival recessions associated with NCCL.

Material and Methods

This randomized, parallel-group clinical study recruited 40 systemically healthy patients, who were admitted to Gazi University Faculty of Dentistry, Department of Periodontology with complaints of sensitivity and aesthetic problems due to gingival recession. The patients were randomly assigned to the study groups: group I, partial restoration with the apical border at the level of CEJ in combination with CAF+CTG; group II, partial restoration with apical border within 1 mm apical to the CEJ.

The location of the CEJ prior to the restorative treatment was identified using the method developed by Zuchelli et al. 2006.

The gingival margin to the most coronal of the NCCL, as well as the width and depth of the NCCL, were measured before and after the restorative treatment. Periodontal parameters were measured with a periodontal probe (UNC 15) at baseline, and 3, 6, and 12 months postoperatively. Plaque index (PI), gingival index (GI), probing depth (PD), bleeding on probing (BOP), clinical attachment level (CAL), recession depth (RD), recession width (RW), keratinized tissue width (KTW), and gingival thickness (GT) were all measured and recorded.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gingival recession of at least 1 mm depth.
  • There is no loss of interdental support (RT-1)
  • Cervical step greater than 0.5 mm
  • Inability to detect CEJ (Class B+)
  • Maximum root closure level at the NCCL's deepest point (Type 3)
  • Individuals who do not have any systemic disease that would preclude surgery
  • Who are not pregnant
  • Who are not smokers or who smoke less than 5 cigarettes per day
  • Who have a whole mouth plaque and bleeding score of 10%
  • Patients who do not require endodontic treatment in the surgical area and do not have tooth mobility;
  • Patients who do not require orthodontic treatment;
  • Patients who do not have periodontal disease; and
  • Patients who do not have restoration and/or filling in the recession area.

排除标准

  • Having a systemic disease that may deteriorate wound healing
  • Poor oral hygiene
  • Patients with active periodontal disease
  • Tooth devitalization

结局指标

主要结局

Change in gingival recession height

时间窗: 12 months after the surgery

Immediately after reconstruction of CEJ, gingival recession height was measured and accepted as baseline value. This value was obtained by the difference between 12th month gingival recession height and baseline recession height

次要结局

  • Mean root coverage(12 months after the surgery)
  • Dental sensitivity by visual analogue scale(12 months after the surgery)
  • Probing depth(12 months after the surgery)
  • Soft tissue thickness phenotype(12 months after the surgery)
  • Complete root coverage(12 months after the surgery)
  • Modified root closure aesthetic score(12 months after the surgery)
  • Self-perceived aesthetic satisfaction by visual analogue scale(12 months after the surgery)
  • Clinical attachment level(12 months after the surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sıla Çağrı İşler

Associate professor

Gazi University

研究点 (2)

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