跳至主要内容
临床试验/NCT03947658
NCT03947658已完成不适用

Influence of Prosthetic Restorative Treatment Timing on Gingival Margin of Teeth After Surgical Crown Lengthening: a Randomized Controlled Pilot Study.

Aristotle University Of Thessaloniki0 个研究点目标入组 18 人开始时间: 2017年1月最近更新:
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
18
主要终点
Relative gingival margin location change

研究概览

简要总结

Setting the restorative margins for teeth with short clinical crowns is challenging and crown lengthening surgery (CLS) is often necessary. The aim of this study was to assess the influence of prosthetic restorative treatment timing on gingival margin location of teeth after crown lengthening surgery.

Eighteen patients requiring CLS were enrolled in the study and divided into two groups depending on the timing of prosthetic rehabilitation, at 6 or fourteen weeks after CLS.Clinical parameters were recorded around treated and neighboring teeth with adjacent and non-adjacent sites at 6 and 14 weeks after surgery as well as three and six months after prosthesis delivery. Alveolar ridge changes were assessed via digital X-rays.Soft tissue healing and the final treatment outcome were assessed by both patients and prosthodontists.

详细描述

Twenty patients selected from those referred to the Department of Periodontics for crown lengthening surgery were enrolled in the study (9 females, 11 males, 19-65 years old, mean age:45.2) Patients were randomly assigned to one of the two experimental groups. For the first group of patients (A), prosthetic restoration started 6 weeks whereas for the second group (B)14 weeks after surgery. After recording of pre-surgical measurements, intrasulcular or internal bevel incisions were performed buccally and lingually, and full-thickness mucoperiosteal flaps were raised. Buccal flaps were reflected to a level beyond the mucogingival junction. The osseous crest and subgingival tooth structure were exposed. The osseous resection was performed after considering the amount of additional tooth structure required for restorative purpose and the preoperative Supracrestal Tissue Attachment at each site with hand and rotary instruments in a manner of establishing positive bone architecture. After root planing, suturing of the surgical sites was performed. The flap margins were placed at or apical to the anticipated crown margin after suturing and as far from the osseous crest as possible and necessary postoperative instructions were given. Patients were recalled 1 week post-surgery for suture removal, oral hygiene reinforcement and healing assessment. Healing was also evaluated at the end of the second post-operative week. All patients were reevaluated at 3 and 6 months after the prosthesis delivery.

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 (Investigator)

入排标准

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

入选标准

  • age ≥ 18 years,
  • periodontally healthy or periodontally treated subjects with Plaque scores ≤15% & GI ≤15%
  • each patient could participate with one tooth only,
  • non-smokers or smokers of less than 5 cigarettes per day,
  • target tooth should be surrounded by both the adjacent teeth which should not be restored,
  • provisional and final prosthetic margins should not extend subgingivally,
  • in case of fracture this should be radiographically detectable,
  • if a root canal treatment was necessary it should have been completed at least 6 months earlier.
  • both anterior and posterior teeth included.

排除标准

  • the presence of syndromes affecting bone metabolism,
  • any kind of contraindication for periodontal surgery,
  • pregnancy or lactation,
  • no compliance with re-examinations or oral hygiene performance
  • cases where gingivectomy or apically repositioned flap without osseous resection were indicated

研究组 & 干预措施

Six weeks group

Experimental

Prosthetic restoration started 6 weeks after surgical crown lengthening

干预措施: Surgical crown lengthening (Procedure)

Fourteen weeks group

Experimental

Prosthetic restoration started 14 weeks after surgical crown lengthening

干预措施: Surgical crown lengthening (Procedure)

结局指标

主要结局

Relative gingival margin location change

时间窗: 6 months after prosthesis delivery (30 to 38 weeks after surgery)

The relative position of free gingival margin as measured from an individualized reference stent in millimeters

次要结局

  • Relative clinical attachment loss(before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery)
  • Gingival bleeding index(before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery)
  • Pocket depth(before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery,at prosthesis delivery, 3 and 6 months after prosthesis delivery)
  • Plaque index(before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery)

研究者

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

Tsachouridou Ioanna

DDS, MSc in Periodontology and Implant Biology, Private practice, Thessaloniki, Greece

Aristotle University Of Thessaloniki

相似试验