Efficacy of Low Intensity Pulsed Ultrasound and Low Level Laser Therapy on Osseointegration and Soft Tissue Healing Following Dental Implant Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Changes in soft tissue healing
研究概览
简要总结
The purpose of the study is to investigate the significance difference between low intensity pulsed ultrasound (LIPUS) versus low-level laser therapy (LLLT) on osseointegration, soft tissue healing, pain pressure threshold and oral health related quality of life in patients post dental implant surgery.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients.
- •Both sexes will be contributed in the study.
- •Non-smokers.
- •Patients who needed dental implant in the maxillary or in the mandible.
- •Bone height and width no less than Class III bone quality assessed clinically and radiologically.
排除标准
- •Medically compromised patients as Uncontrolled diabetes mellitus.
- •Patients indicated for bone graft at the implant site.
- •Patients under chemotherapy or radiotherapy in facial region.
- •Poor oral hygiene.
- •Patients with any history of temporomandibular joint disorders.
- •Patients with any other periodontal and oral surgeries
结局指标
主要结局
Changes in soft tissue healing
时间窗: Changes in soft tissue healing immediately postoperative, after 6 weeks and after 3 months
Landry index for soft tissue healing will be used to measure soft tissue healing. The healing index (HI) evaluates healing based on redness, presence of granulation tissues, bleeding, suppuration, and epithelialization. A score of 1-5 was given with score 1 for very poor healing and 5 being excellent healing of the tissues. Higher scores indicate better healing rates. This index assesses the surgical wound by clinical examination.
Changes in Osseointegration
时间窗: Changes in Osseintegration immediately postoperative, after 6 weeks and after 3 months
X-ray Radiograph will be performed for each patients and then analyzied by Specialized software to evaluate the osseointegration between bone and implant surface. The radiographs will be taken in high-resolution mode (Vista Scan Durr Dental, Durr Dental Italy S.r.l) with a dental X-ray machine (TM 2002 Planmeca Proline CC, Planmeca Group Helsinki, Finland) equipped with a long tube that operated at 70 Kw/7.5 mA. Specialized software (DBSWIN software, Durr Dental Italy S.r.l) will be used for linear measurements of marginal bone changes
次要结局
- Changes in Pain pressure threshold(Changes in Pain pressure threshold immediately postoperative, after 6 weeks and after 3 months)
- Changes in oral quality of life(Changes in oral quality of life immediately postoperative, after 6 weeks and after 3 months)
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University