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临床试验/NCT04459494
NCT04459494已完成不适用

Evaluation of Dental Implant Treatment With and Without Flap for Clinical, Radiographic and Patient Comfort

Izmir Katip Celebi University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年10月15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
24
试验地点
2
主要终点
Early marginal bone loss around implant neck.

研究概览

简要总结

The aim of this clinical study is to compare two different approaches during dental implant applications. One group of patients in the study received flapless approach which is performed without surgical reflection of soft tissues (gums) during implant surgery. In the control group of the study, patients received conventional flap approach in which flap reflections performed on soft tissues (gums) of the patients.

After the surgery patients were monitored for marginal bone loss around implants and discomfort after the surgery for 3 months. And received data statistically analyzed to compare the different surgical procedures.

详细描述

Filling the Case Report Form for each registered patient and signed by the responsible investigator or an authorized representative of the study staff. This also applies to records for patients who could not complete the study (even if a case report form was prepared, even during screening prior to randomization). If a patient withdraws from the study, the reason for this is recorded in the Case report form. If a patient withdraws from the study because of a limiting adverse event, all necessary efforts will be made to clearly document the result.

All forms must be filled with a typewriter or an indelible ink pen and must be readable. Errors can be crossed out, but errors cannot be deleted; the correction is entered and the change is initialed and dated by the investigator or his authorized representative. The researcher should ensure the accuracy, completeness and legibility of the data reported to the sponsor in the case report forms and all required reports and that it was processed on time.

The researcher is responsible for the accuracy of the data transferred on the forms and will sign these forms in the sense of showing their compatibility with the recorded data.

As a result of the power analysis made with G * Power3.1 (Franz Faul, UniversitätKiel, Germany) software program, it has been determined that the sampling number consisting of 20 people with 0.8 effect size and α = 0.05 significance level generates more than 80% power. it was deemed appropriate to include a total of 24 people in the study. Karim M. Ahmed A, Salah Abd Elfatah B, Mohamed Abd El-Mageed Katamish's ''Crestal bone loss of standard implant versus platform switch implant design using minimal invasive technique'' article is used as a reference for marginal bone loss data calculation.

Patients with sufficient amount of bone were included in the study after bone sounding and x rays were evaluated after local anesthesia before surgery. By an unbiased researcher, the patients were recruited to the groups using the envelope method; control group (with flap raised) or test group (without flap raised) were assigned.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy (The determination of healthy volunteers will be based on the patient's statements in the anamnesis received. Additional examinations will not be performed.)
  • Not smoking,
  • Does not have a medication that he constantly uses,
  • who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months,
  • Patients who are not in pregnancy, lactation, menstruation or menopause,
  • Patients with at least 1 tooth deficiency,
  • Patients who accepted the research and signed the informed volunteer consent form

排除标准

  • Regularly using a systemic medication,
  • During pregnancy, lactation, menstruation or menopause,
  • Have any oral or systemic diseases,
  • Receiving antibiotic, anti-inflammatory or systemic corticosteroid drug treatment in the last 6 months,
  • Patients with no teeth deficiency

结局指标

主要结局

Early marginal bone loss around implant neck.

时间窗: Immediately after implant placement - 3 months after surgery.

Bite wing x-rays taken with parallel technique for both groups were evaluated and recorded between the baseline and the 3rd month around the implant neck.

次要结局

  • Visual analog scale -Patient discomfort after surgery.(Immediately after implant surgery - 3 days after surgery - 7 days after surgery .)
  • The Turkish translation of Oral Health Impact Profile (OHIP-14) forms - Patient discomfort after surgery.(Immediately after implant surgery - 3 days after surgery - 7 days after surgery .)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erkan SARI

Research Assistant Dentist

Izmir Katip Celebi University

研究点 (2)

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