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临床试验/NCT04922086
NCT04922086已完成不适用

The Effectiveness of Digital Planning and Guided Dual Technique in Aesthetic Crown Lengthening: A Randomized Controlled Clinical Trial

Universidade Federal de Alfenas2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change of clinical crown length.

研究概览

简要总结

Excessive gingival exposure, commonly named gingival smile, results in a dentogingival disharmony. One of the gingival smile treatment is the aesthetics-related crown lengthening surgery (ACL) to provide a adequate clinical crown length and diminish gingival display. In this context, digital planning and guided dual technique have been proposed to increase the effectiveness and predictability of the ACL. In this technique, an facial and dental analysis of the patient is performed and transferred to a digital model obtained by intraoral digital scan. The digital model is used to create a double guide that will determine the final position of the gingival and alveolar margin in the ACL. Despite the technique showing promising results, clinical studies evaluating the effectiveness of this technique are scarce. The present study aims to evaluate the digital planning and guided dual technique in the ACL in comparison to conventional technique in relation to the predictability/stability of the gingival margin positioning and patient satisfaction after the ACL. Twenty-four patients diagnosed with altered passive eruption type I subcategory B will be selected and divided into two groups. In the control group (n = 12) patients will be submitted to the conventional ACL planned using clinical examination; in the test group (n = 12) patients will be submitted to ACL using cone beam computed tomography (CBCT), digital planning and guided dual technique. Periodontal clinical parameters including probing depth (PS), clinical attachment level (CAL), clinical crown length (CCL), anatomical crown length (ACL) and cemento-enamel junction to alveolar bone crest distance will be evaluated clinically at baseline, in the immediate postoperative, 4, 8 and 12 months after the procedure. Participants will be submitted to questionnaires to assess satisfaction with the smile, gum and tooth characteristics and experience with the procedure. The investigators aim to demonstrate with the study the effectiveness of the both techniques and evaluate the clinical cost benefit for the patient and the dentist of the guided dual technique in relation to the conventional ACL technique.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Non smokers;
  • Periodontal and systemically healthy;
  • Patients with more than 20 teeth including the six maxillary anterior teeth;
  • Altered passive eruption diagnosis (classified as type I subcategory B) in the quadratic anterior teeth.

排除标准

  • Orthodontic treatment;
  • Presence of prosthetic crowns;
  • Extensive restorations;
  • Extensive incisal edge attrition;
  • Misalignment on maxillary anterior teeth.

结局指标

主要结局

Change of clinical crown length.

时间窗: Baseline, immediately after the intervention, 4, 8 and 12 months.

Measured as the distance between incisal edge and gingival marginal using a periodontal probe and its will determine the stability of the gingival margin in the both groups. The clinical crown length will be also measured using a cone beam computed tomography (CBCT)

次要结局

  • Change of anatomic crown length.(During the intervention.)
  • Change of gingival display.(Baseline, 4, 8 and 12 months.)
  • Change of gingival width.(Baseline, immediately after the intervention, 4, 8 and 12 months.)
  • Change of gingival margin position.(Baseline, 4, 8 and 12 months.)
  • Change of clinical attachment level(Baseline, 4, 8 and 12 months.)
  • Change of gingival thickness.(Baseline.)
  • Distance between cemento-enamel junction and bone crest.(During the intervention.)
  • Change of probing depth.(Baseline, 4, 8 and 12 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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