Investigating Periapical Healing Following Endodontic Microsurgery Using Autologous Grafts With or Without Photobiomodulation A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Clinical Assessment of soft tissue healing and postoperative pain.
研究概览
简要总结
Primary Purpose of the Study
The primary purpose of this randomized, double-blinded clinical study is to evaluate and compare the periapical healing outcomes following Endodontic Microsurgery and Platelet-Rich Fibrin (PRF) placement , with and without adjunctive Photobiomodulation Therapy (PBMT), using clinical, radiographic, ultrasonographic (with color Doppler), and CBCT imaging methods over a 12-month follow-up period.. This study seeks to determine whether the combination of regenerative [ using PRF] and adjunctive therapies [using PBMT] enhances tissue regeneration, reduces inflammation, and improves overall clinical outcomes compared to conventional treatment approaches
Endodontic microsurgery (EMS) has shown high success rates in managing persistent periapical pathosis, especially with advancements in microsurgical techniques, imaging modalities like CBCT and Ultrasonography with Color Doppler, and the use of regenerative biomaterials such as Platelet-Rich Fibrin (PRF). PRF enhances healing by releasing a concentrated mix of growth factors that promote tissue regeneration and angiogenesis. Photobiomodulation Therapy (PBMT), also known as low-level laser therapy, has demonstrated additional regenerative potential by stimulating cellular proliferation, improving microcirculation, and reducing postoperative inflammation and pain. Combining PRF with PBMT may synergistically enhance periapical healing following EMS by accelerating tissue repair and improving bone regeneration outcomes. This study seeks to investigate whether adjunctive PBMT offers significant benefits over PRF alone in post-surgical periapical healing assessed through clinical, radiographic, ultrasonographic (with color Doppler), and CBCT evaluations.
MATERIAL 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, King George’s Medical University, Lucknow. The study aims to include patients of age group 18 to 40 years with radiographic evidence of periapical lesion indicated for surgery and who will give a written consent and adhere in the inclusion criteria of the study. They will be categorized into two groups based on use of photo biomodulation therapy.
Surgery under magnification followed by placement of PRF will be done in all patients. Following which PBMT will be applied in study group and laser simulation without activation will be done in control group. Clinical , radiographical evaluation will be done to evaluate the periapical healing at required intervals. Ultrasonographic with color doppler study and CBCT evaluations will also be done at required intervals to assess neo angiogenesis and three dimensional bone fill respectively.
Data obtained will be statistically analysed. Any changes deemed in the interest to the study will be done accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 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
- •1.All patients within 18–40 years of age who will give a written consent to participate in the study 2.Single rooted, maxillary anterior teeth.
- •3.Teeth with peri apical radiolucency indicated for surgery.
- •4.Patient should be of sufficient mental capacity and be in possession of all essential information.
- •5.Patients who are not on any medication affecting periapical healing.
- •(corticosteroids, chemotherapeutic agents, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, anticoagulants and drugs which reduce osteoblastic activity).
排除标准
- •1.Patients who did not give their consent for participating in the study.
- •2.Patients having insufficient motivation to report back for follow up visits.
- •3.Patients with any systemic diseases like diabetes mellitus, hypertension, hepatitis, Human immunodeficiency virus, bone disorders, auto-immune disorders.
- •4.Surgical retreatment cases.
- •5.Patients with malignant tumors or undergoing chemotherapy/radiotherapy.
- •6.Pregnant females.
- •7.Patients with periodontally compromised teeth.
结局指标
主要结局
Clinical Assessment of soft tissue healing and postoperative pain.
时间窗: Clinical Assessment to be done at 24 hrs, 3 days and 7 days postoperatively | Radiographic Assessment to be done at 1 month and every 3 month interval upto 1 year
Radiographic Assessment of healing.
时间窗: Clinical Assessment to be done at 24 hrs, 3 days and 7 days postoperatively | Radiographic Assessment to be done at 1 month and every 3 month interval upto 1 year
次要结局
- Assessing soft tissue healing and increase in microvascualture using Ultrasonography with Color Doppler and 3D bone fill using CBCT(Ultrasonography with Color Doppler to be done at 3,6, 9 and 12 months.CBCT Assessment to be done at 6 months and 1 year)