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临床试验/NCT04409366
NCT04409366已完成不适用

One- Versus Two-Stage Aesthetic Crown Lengthening for Restorative Purposes: A Randomized Controlled Trial.

Universidad Complutense de Madrid0 个研究点目标入组 30 人开始时间: 2013年4月1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
入组人数
30
主要终点
T1-T4

研究概览

简要总结

This randomized controlled trial was aimed at assessing the efficacy of a two-stage crown lengthening intervention (SCL) for restorative purposes in the aesthetic zone compared with a one-stage crown lengthening procedure (CCL).

详细描述

Subjects were randomly allocated to receive SCL or CCL. SCL consisted of full thickness flaps followed by bone recontouring and minor gingivectomy 4 months postoperatively, if required. In CCL, osseous recontouring after sub-marginal incisions was performed, followed by flap repositioning. Records were obtained at baseline, 4 months (only in SCL), 6 and 12 months. Primary outcome was the precision in achieving a predetermined gingival margin position. Other outcomes were changes in the gingival margin position and keratinized tissue width (KTW) at 12 months, and patient-reported outcomes (PROMs) using the OHIP-14 tool.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •older than eighteen years of age;
  • •more than 20 teeth in the mouth;
  • •with full mouth plaque and bleeding scores lower than 15%; and
  • •without probing pocket depth and/or attachment loss >4 mm

排除标准

  • •Pregnant women or breastfeeding
  • •treated with antimicrobial and/or anti-inflammatory drugs within two months prior to entering the study
  • •currently undergoing orthodontic therapy

研究组 & 干预措施

Conventional Crown Lengthening; CCL

Active Comparator

Using the surgical guide, submarginal internal bevel incisions were performed on the buccal aspect of the affected teeth. A full-thickness flap was raised up to the mucogingival junction (Dominguez et al., 2020). Ostectomy and osteoplasty were carried out by means of rotatory instruments and surgical chisels, as necessary, to achieve the necessary space between the bone crest and the restorative margin according to the presurgical plan. The CEJ was not the reference point since, in many cases, the position of the final margin of the restoration was planned apical to the actual position of the CEJ. Exposed root surfaces were carefully instrumented manually with curettes and, finally, vertical internal mattress sutures were placed to position the gingival margin at the level of the margin of the planned restoration. Sutures were removed after 7 days.

干预措施: Conventional Crown Lengthening (CCL) (Other)

Two-stage Crown Lengthening (SCL)

Experimental

In the first surgical intervention, intrasulcular incisions were performed and a full thickness flap was raised up to the mucogingival junction. Ostectomy and osteoplasty were performed to establish the space for supracrestal tissue attachment, following the restorative plan and using the presurgical blueprint as the reference to determine the final position of the restoration margin, instead of the CEJ (Lee, 2004). Then the flaps were repositioned and secured with internal mattress sutures, placing the gingival margin at the original level. Sutures were removed at 7 days. In the second stage, after 3-4 months, minor gingival recontouring was performed, if necessary, to attain the desired gingival margin position according to the presurgical plan

干预措施: Two-stage Crown Lengthening (SCL) (Other)

结局指标

主要结局

T1-T4

时间窗: Baseline-12 months

The difference in mm between the ideal gingival margin (T1) and the position of the gingival margin at 12 months (T4).

次要结局

  • Clinical Crown Length(At baseline, 6- and 12-month)
  • Gingival display upon smiling(At baseline, 6- and 12-month)
  • Amount of keratinized tissue(At baseline, 6- and 12-month)
  • Supracrestal tissue dimension(At baseline, 6- and 12-month)

研究者

申办方类型
Other
责任方
Sponsor

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One- Versus Two-Stage Aesthetic Crown Lengthening | 临床试验