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临床试验/NCT03413553
NCT03413553已完成不适用

Clinical Evaluation of Soft Tissue Augmentation Using Connective Tissue Graft and Platelet Rich Fibrin Around Immediately Placed Dental Implants Versus Immediate Implant Alone in Esthetic Zone

Abeer hassan sharafuddin1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Pink Esthatic score

研究概览

简要总结

The main hypothesis to be certified is that the addition of Subepithelial Connective Tissue Graft (SCTG) and Platelet rich Fibrin (PRF) to immediately placed implants will not significantly differ from immediately placed implant alone as regard gingival tissue stability.

详细描述

  • The primary objective Evaluation of connective tissue graft and platelet rich fibrin combined with immediate implant placement as an innovative option for more pink esthetic score, versus immediate implant alone.
  • The secondary objective Evaluation of patient satisfaction, width of keratinized mucosa, crestal bone level after the use of platelet rich fibrin and connective tissue graft combined with immediate implant versus immediate implant alone.
  1. Trial design:
  • A Randomized clinical trial.
  • Uni center: A trial will be carried out in one hospital.
  • Equal randomization: participants with equal probabilities for intervention.
  • Positive controlled: Both groups receiving treatment.
  • Parallel group study: Each group of patients receives a single treatment simultaneously.
  • Two assessors will assess the result (1st Assessor Perryhan.M.) & (2nd Assessor Nada Farouk)

Methods: Participants, interventions, and outcomes 9. Study setting: This study will be carried out on patients attending outpatient clinics in Oral Medicine, Diagnosis and Periodontology Department- Faculty of Dentistry Cairo University-Egypt. Post graduate Periodontology clinic 1st floor old section. Sirona dental units with LED light.

Preoperative measures (for both groups):

  • Phase I therapy (Supragingival scaling, subgingival debridement and oral hygiene instructions) should apply for the two groups before any surgical procedures.
  • 4 weeks later both groups will be examined to determine patient compliance with oral hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash* twice daily).
  • Radiographic measurements for marginal bone changes will be performed at baseline ( time of implant placement), three months and six months after implant placement or crown construction. Intra oral periapical radiographs performed with paralleling technique will facilitate bone level measurement on distal and mesial aspects of the implant . The highest coronal area of healing abutment will be recorded as a static reference line.
  • Width of keratinized mucosa measured at the line of mucogingival junction to the groove of free gingiva by Williams graduated periodontal probe 1 using the roll technique.
  • Ttissue biotype measured after anasthesia application and percing the keratinized gingiva perpendicular to the tooth against the alveolar bone. using Williams graduated periodontal probe .
  • Crestal bone level at the mesial and distal side of each implant was measured with using Kodak D speed films with a reference point before and after the surgical procedure.
  • Study casts for case study will be fabricated.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pink Esthatic score

时间窗: should be measured after 6 months below implant and graft placement

measured by clinical evaluation. The PES contains the following seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture at the facial aspect of the implant site.(26) It is measured as score (0-14), 0 is the lowest score and 14 is the highest score

次要结局

未报告次要终点

研究者

发起方
Abeer hassan sharafuddin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abeer hassan sharafuddin

Assistant lecturer of Oral Diagnosis, Oral Medicine and Periodontology, Queen Arwa University.- yemen

Cairo University

研究点 (1)

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