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临床试验/NCT03179683
NCT03179683已完成不适用

Radiographic Evaluation of Low Level Laser Therapy Enhanced Maxillary Sinus Augmentation With Simultaneous Implant Placement

Ugur GULSEN0 个研究点目标入组 12 人开始时间: 2011年10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
12
主要终点
Bone density analysis

研究概览

简要总结

This randomized controlled split-mouth clinical trial study was designed to evaluate the effects of low-level laser therapy on bone healing in patients with bilateral sinus lifting and simultaneous dental implant application.

Maxillary posterior partially edentulous or totally edentulous twelve patients who need bilateral sinus bone augmentation were included in this study. Sinus bone augmentation and dental implant surgeries were done simultaneously. Low level laser therapy (LLLT) was (λ= 630-660 nm, 25 mw / cm², 6 mins) applied for just one operation side at first, third, fifth and seventh days. Treatment side were randomly selected by another surgeon who applied LLLT. Panoramic radiographs were taken at the first, third and sixth months using aluminum step-wedge technique. Optic Density analyses were performed using Cardinal Health Digital Densitometer (Fluke Biomedical 07-443) with 1mm diameter. Digital densitometric results were obtained as equivalent aluminum thickness for each radiograph. These data were used to evaluate changes in optical bone densitometry and compare the LLLT applied side and control side for each patient.

详细描述

Twelve patients were included to this study who required a bilateral sinus floor augmentation for implant-prosthetic rehabilitation. Nine patients were bilaterally free-end partial edentulous and three patients were totally edentulous with residual alveolar height between 3-6 mm. All patients required bilateral sinus augmentation with simultaneous implant placement.

Patients who have maxillary sinus pathology, previous history of chronic sinus infection, smoking more than ten cigarettes per day, any systemic disease interfere with the surgical procedure were excluded from study.

The study protocol was conducted by Ankara University Dentistry Faculty Research Ethics Committee. All patients were informed about the treatment procedure and all patients gave written consent for participation.

Surgical Protocol Bilateral sinus augmentation and simultaneous implant placement were performed in one appointment with same surgical protocol. All surgical procedures performed under local anesthesia (Ultracain D-S Forte; Sanofi-Aventis, Istanbul, Turkey). After elevation of mucoperiosteal flap a hinge door osteotomy was performed on the lateral wall of the maxillary sinus with a round diamond bur under saline solution irrigation. Schneiderian membrane was carefully detached from inferior and lateral walls of the sinus until creating enough space for placement of bone grafts. Implant osteotomies were performed and DBM putty bone graft (DynaGraft bone putty, Keystone Dental, Burlington, Mass) were placed medial, posterior and anterior side of implant sockets. Implants (Touareg S, Adin, Afula, Israel) were inserted into the osteotomy site after sufficient grafting. Access window filled with bone graft after implant placement. Membrane was not used over access window. 3/0 silk suture were used for closure of the flap. Antibiotic (amoxicillin thrice per day), analgesic (naproxen sodium, 2 twice per day) and mouthwash (isotonic saline twice per day) were prescribed for postoperative management. The patients were advised to have a soft diet and to avoid sneezing until two weeks. Sutures were removed one-week after surgery. No complications occurred during surgery. All surgical wounds healed uneventfully.

Low Level Laser Therapy Protocol In this study, an 630-660 nm aluminum gallium indium phosphide (AlGalnP) laser device (Scorpion Dental Optima Model 405-7A; Optica Laser, Sofia, Bulgaria) was used immediately after surgery, third day, fifth day and seventh day only for one operation side. Treatment side were randomly selected by another surgeon who applied LLLT. Tissue was irradiated at 25mW power for total six minutes, two minutes for each point (buccal, palatal, crestal). 72J /cm2 energy density was deposited in one session.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Twelve patients were included to this study who required a bilateral sinus floor augmentation for implant-prosthetic rehabilitation. Nine patients were bilaterally free-end partial edentulous and three patients were totally edentulous with residual alveolar height between 3-6 mm. All patients required bilateral sinus augmentation with simultaneous implant placement.

排除标准

  • Patients who have maxillary sinus pathology, previous history of chronic sinus infection, smoking more than ten cigarettes per day, any systemic disease interfere with the surgical procedure were excluded from study.

结局指标

主要结局

Bone density analysis

时间窗: Change from Baseline in Bone Density at 6 months

Panoramic radiographs were taken using with aluminum step-wedge technique. These images were used to evaluate changes in optical bone densitometry.

次要结局

未报告次要终点

研究者

发起方
Ugur GULSEN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ugur GULSEN

Principal investigator

Bulent Ecevit University

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