Clinical and radiographic assessment of soft and hard tissue healing with low level laser therapy following endodontic surgery: A randomized clinical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluate change in the size of the periapical defect after endodontic surgery following low level laser therapy.
研究概览
简要总结
Apical surgery is considered a standard oral surgical procedure. It is often a last resort to surgically maintain a tooth with a periapical lesion that cannot be managed with conventional endodontic (re-)treatment. The main goal of apical surgery is to prevent bacterial leakage from the root-canal system into the periradicular tissues by placing a tight root-end filling following root-end resection.1
The success of periapical surgery has been assessed with the same clinical and radiographic criteria as for nonsurgical root canal treatment. However, many previous studies stated that the radiographic rate of bone regeneration for successful periapical healing after endodontic surgery are different from those for nonsurgical root canal treatment.2,3
To further enhance the rate of Radiographic and clinical outcome following endodontic surgery many advancements have been introduced in the field of dentistry, one such advancement is the use of Low Level Laser therapy. The use of Low-Level Laser Therapy (LLLT) is known to influence the healing process through biostimulation, helping to reduce pain and swelling without any side effects, while promoting tissue healing.7 Numerous controlled studies have demonstrated the beneficial effects of LLLT at both the cellular and histological levels.10,11 LLLT induces vasodilation, which enhances local blood circulation11, bringing more oxygen to the area and promoting the migration of immune cells to the affected tissue. Additionally, it causes relaxation of the smooth muscle in the blood vessel walls, further accelerating tissue repair.19
The radiographic assessment of Low Level Laser therapy in regards with its outcome on healing of hard tissue is done using CBCT, though Conventional radiography is the most common and routine radiographic procedure employed still it does not provide conclusive evidence on the extent or limits, dimensions, content of the lesions.22,23 3D compression , geometric alterations of anatomic structures and obscuring important anatomic details.
Cone Beam Computed Tomography (CBCT) is an advanced imaging technique that offers precise three-dimensional (3D) view of the maxillofacial complex tissue structures and the relationship among anatomical structures. Using CBCT in endodontics enables a three dimensional comprehensive evaluation of the area of interest and improved resolution, providing a detailed analysis of the tooth and surrounding tissue. Furthermore, CBCT offers excellent dimensional accuracy with only about 2% magnification, making it an ideal tool for diagnostic purposes.12
To assess the enhancement of blood circulation and neoangiogenesis in the area of defect Colour Doppler Ultrasonography is used. During the first healing phase, new blood vessels in the bone gradually form. Angiogenesis is a critical component of bone repair. Inflammatory cells, precursor cells, and the metabolically active regenerating callus are recruited to the injury site with the help of essential nutrients and oxygen supplied by the newly developing blood vessels. Therefore, using Colour Doppler in this study will enable us to assess neo-vascularisation, a vital process in bone healing.
The goal of this study is to thoroughly investigate the potential clinical and radiographical advantages of LLLT in improving the healing of both soft and hard tissues following endodontic surgery.4
AIMS AND OBJECTIVES:
Aim:
The aim of this randomized study is to evaluate possible benefits of Low Level Laser therapy (LLLT) on soft and hard tissue healing after endodontic surgery.
The study had the following objectives:
Primary Objective:
· To assess the clinical and radiographic outcomes of Low Level Laser Therapy on soft and hard tissue healing post endodontic surgery.
Secondary Objective:
· Radiographic and Ultrasonographic investigation for possible association of bone regeneration following low level laser therapy.
MATERIALS AND METHODS:
The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow in collaboration with Department of Radiodiagnosis and Department of Oral Medicine and Radiology, KGMU, Lucknow.
The study will be conducted only after getting clearance from Institutional Ethical Committee and registration in CTRI.
Suitable number of patients with periapical bone defects who will give the written consent will be selected and randomized into 2 test groups.
Periapical endodontic surgery will be performed in all the groups. Following the periapical surgery one Group will be subjected to Low Level Laser Therapy following a specific protocol at regular interval. The results will be evaluated against a control group in which no Low Level Laser Therapy will be given.
Clinical and radiographic evaluation of these patients will be done at required time interval.
The obtained data will be subjected to statistical analysis.
Any changes if found necessary will be done in the interest of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients within 18-40 years of age.
- •Single rooted, anterior teeth with periapical radiolucency indicated for surgery.
- •patients who are not on any medication affecting periapical healing.(Corticosteroids, chemotherapeutic agents, non steroidal anti inflammatory drugs, antibiotics, anticoagulants and drugs which reduce osteoclastic activity).
排除标准
- •1.Patients who did not give their consent for participating in the study.
- •2.Patients with any systemic diseases like diabetes mellitus, hypertension, hepatitis, Human immunodeficiency virus, bone disorders, auto immune disorders.
- •Surgical retreatment cases.
- •Patients with malignant tumors or undergoing chemotherapy, radiotherapy.
- •Pregnant females.
- •Patients with periodontally compromised teeth.
结局指标
主要结局
Evaluate change in the size of the periapical defect after endodontic surgery following low level laser therapy.
时间窗: At baseline, 3 month and 6 month
次要结局
- Evaluation of Neo-angiogenesis in the periapical defect after endodontic surgery using color doppler.(At baseline, 3 month & 6 month)
研究者
Dr Anshuman Rai
King Georges Medical University
