Clinical Outcomes of Immature Teeth Treated With Regenerative Endodontic Procedures Using Intracanal Delivery of Omega-3 Fatty Acids
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Increase in Root Length
研究概览
简要总结
This clinical study will be conducted to evaluate the effect of using intracanal Omega-3 Fatty acids during revascularization of necrotic immature teeth compared to the traditional induced bleeding technique.
详细描述
Immature permanent teeth with pulp necrosis have thin, fragile dentinal walls, making conventional endodontic sealing techniques challenging. Regenerative endodontics (RE) offers a biologically based alternative that enables continued root development, apical closure, and potential restoration of vitality through approaches such as tissue engineering and revascularization. These procedures rely heavily on the survival and differentiation of stem cells from the apical papilla, even in the presence of infection.
Inflammation plays a pivotal role in RE, influencing both healing and regenerative outcomes. Specialized pro-resolving mediators (SPMs), derived from omega-3 and omega-6 fatty acids, actively resolve inflammation and promote tissue regeneration. Among them, Resolvin E1 (RvE1), derived from EPA, has shown potent anti-inflammatory and pro-regenerative effects, including inhibition of leukocyte infiltration and enhancement of dental pulp stem cell recruitment. Experimental studies demonstrated that intracanal RvE1 reduced periapical inflammation and promoted root development more effectively than traditional intracanal medicaments.
Omega-3 polyunsaturated fatty acids (ω-3 PUFAs), particularly EPA and DHA, have been widely studied in dentistry for their anti-inflammatory and regenerative properties. Evidence from animal studies and clinical trials indicates that ω-3 PUFAs reduce inflammatory mediators, suppress bone resorption, enhance new bone formation, and support stem cell proliferation and differentiation, even under inflammatory conditions. Clinically, ω-3 PUFAs have shown benefits in periodontal therapy, oral mucositis, and other inflammatory oral diseases.
Despite these promising findings, clinical evidence supporting the use of ω-3 PUFAs in endodontics remains limited. Further research is needed to evaluate their role in regenerative endodontic procedures, particularly in necrotic immature teeth where mechanical disinfection is restricted and preservation of apical stem cells is critical. The proposed hypothesis is that ω-3 PUFAs may enhance regenerative endodontic outcomes by modulating inflammation and supporting tissue regeneration.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 28 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 6 and 28 years.
- •Systemically healthy patients with no history of systemic diseases.
- •Patients with necrotic immature permanent teeth due to trauma and/or caries.
- •Preoperative radiographic evidence of incomplete root formation.
- •Wide apical foramen (apical diameter ≥ 1 mm).
- •Thin dentinal walls on preoperative radiographs.
排除标准
- •Patients with known allergy to any of the drugs used in the study.
- •Patients with systemic diseases or medically compromised conditions.
- •Grossly decayed or fractured teeth requiring post and core restorations.
- •Presence of draining sinus tract.
- •Presence of periodontal pockets.
- •Radiographic evidence of external or internal root resorption.
- •Patients with a history of major surgeries (e.g., cardiac surgery, kidney transplantation).
- •Patients undergoing hemodialysis.
研究组 & 干预措施
Group 1 ( Control ) : Traditional induced bleeding technique
A sterile K-file will be inserted 2 mm beyond the canal terminus to induce bleeding and blood clots inside the canal. The canal orifice which is located in the cervical part of the root canal, measuring 2-3 mm, will be sealed using a white mineral trioxide aggregate (MTA) orifice plug. Then, the access cavity will be sealed using bulk-fill flow composite
干预措施: Calcium Hydroxide (Ca(OH)2) (Drug)
Group 2: Induced bleeding technique with application of Omega-3 Fatty Acids
The procedure will be identical to that of the first group, except that the ω-3 PUFAs (prepared at the Department of Pharmacognosy, Faculty of Pharmacy, Mansoura University) will be delivered into the root canal during the revascularization procedure. The canal orifice will be sealed in the same manner as in the first group.
干预措施: Omega -3 fatty acids (Drug)
Group 2: Induced bleeding technique with application of Omega-3 Fatty Acids
The procedure will be identical to that of the first group, except that the ω-3 PUFAs (prepared at the Department of Pharmacognosy, Faculty of Pharmacy, Mansoura University) will be delivered into the root canal during the revascularization procedure. The canal orifice will be sealed in the same manner as in the first group.
干预措施: Calcium Hydroxide (Ca(OH)2) (Drug)
结局指标
主要结局
Increase in Root Length
时间窗: 12 months
Radiographic increase in root length (Millimeters (mm))
Periapical Bone Formation
时间窗: 12 months
Radiographic evidence of periapical bone formation
Increase in Dentinal Wall Thickness
时间窗: 12 months
Radiographic increase in dentinal wall thickness measured using digital image analysis ( Millimeters (mm) )
次要结局
未报告次要终点
