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临床试验/NCT02999880
NCT02999880Unknown不适用

Clinical Performance of Direct Anterior Composite Restorations Using Innovative Esthetic Dual-Shade Versus Polychromatic Natural Layering Technique Randomized Clinical Trial

Cairo University0 个研究点目标入组 2 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2
主要终点
Patient satisfaction

研究概览

简要总结

the importance of this study is to evaluate the clinical performance of direct anterior resin composite restoration constructed using innovative esthetic dual-shade technique and another restoration constructed using polychromatic natural layering technique with various finishing and polishing steps.

The benefit from carrying out this study is to help the practitioners to decide the most suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with superior clinical performance direct anterior resin composite restoration.

详细描述

-Study setting: Study is to be conducted in the Conservative Dentistry Department - Cairo University.

  • Interventions:
  1. Preoperative clinical assessment:

(O.S) will diagnose and select patients according to inclusion and exclusion criteria. He will record all base line data with understanding of patients' chief complains and aesthetic needs after treatment. Moreover, he will provide guidance for patients to prepare for the study.

  1. (A.H) and (G.Z) will take standard preoperative digital photographs before intervention by modifying mobile camera with smile lite (made in Switzerland) and smile capture 2016 contain 10 adaptors to allow connection between smile lite and the smartphone then photos will be saved in a computer.
  2. (A.H) and (G.Z) will take color shade using both Vita shade guide and Vita-Easy shade compact.
  3. .(A.H) and (G.Z) will ask patient for his satisfaction will be taken by visual analogue scale (0-100mm), 0 score refer to not satisfied at all, while 100 score refer to totally satisfied.
  4. (G.Z) and (A.H) will carry out all these tests at baseline, immediately after, 6 and 12 months in post-operative follow-up visits.
  5. Pre-operative planning (O.S) will be responsible for randomization according to patient selection for the sealed envelope containing which half will receive the control and the other will receive the intervention (Split mouth technique). Control group will be performed using polychromatic composite layering technique .Intervention group will be performed using dual shade composite layering technique.
  6. Intraoperative procedure: (G.Z) will do the following procedures:
  • Silicone matrix will be fabricated either directly in the patient mouth using lingual surface of the remaining tooth structure and the existing restorations as a guide ,or fabricated on a study cast after optimizing the shape and function of the teeth with a wax up.
  • Teeth preparation: after complete removal of caries a 1.5mm 75° functional- esthetic enamel bevel will prepared using 8888 diamond bur ( Brasseler, Savannah, GA, USA) on the facial surface, the lingual bevel will be 45° functional bevel, then a coarse disc (sof-lex,3M ESPE) will be used to extend the facial bevel where needed interproximally and toward the gingival third of the facial surface.
  • Cleaning the teeth surface with fluoride-free paste(Depurdent, Dr Wild AG) and water.
  • Teflon tape will placed on the adjacent teeth to prevent there being etched.

Application of each material is done according to the manufacture instructions:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, 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

  • •Inclusion Criteria for participants:
  • •Patients with good general health.
  • •Patients who will agree to the consent and will commit to follow-up period.
  • •Fully erupted anterior teeth with defects.
  • •Active caries, fractures, or defective Restorations in 6 anterior teeth.
  • •At least one spot lesion for contra-lateral anterior teeth on each side in the same jaw

排除标准

  • •Exclusion criteria for participants:
  • •Patients with any systemic disease that may affect normal healing.
  • •Patient with bad oral hygiene.
  • •Tetracycline or florsis staining.
  • •Patients who could/would not participate in all times of follow-up.
  • •Untreated periodontal disease was not allowed.
  • •Patients participating in more than 1 dental study.
  • •Patient received fluoride varnish during orthodontic treatment.
  • •Fully erupted anterior teeth with no defects.
  • •Patients with tendency to do bleaching during the study.

研究组 & 干预措施

Polychromatic layering (Control):

Experimental

Using and mixing different composite shades, opalescents and intensives.

干预措施: Polychromatic layering (Procedure)

Dual-shade layering (Intervention):

No Intervention

Only two composite resin material shades the opaque dentin composite and enamel shade composite.

结局指标

主要结局

Patient satisfaction

时间窗: Change in satisfaction from baseline, after6 months and 0ne year

Scale 0-100 cm, 0 is unsatisfied at all, 100 satisfied totally.

次要结局

  • Color shade(change in shade from baseline, after six months and one year)

研究者

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

Ghada Ahmed Elzayat

principle investigator

Cairo University

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