Biomarkers as Indicators of Periapical Healing Following Root Canal Treatment in Teeth With Apical Periodontitis: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Radiographic Healing of Apical Periodontitis
研究概览
简要总结
This prospective observational cohort study will evaluate whether changes in gingival crevicular fluid osteoprotegerin (OPG) , RANKL/OPG ratio ,IL10,IL8and CxCL10 after primary nonsurgical root canal treatment are associated with 12-month radiographic healing in teeth with asymptomatic apical periodontitis. Participants will undergo standardized treatment and follow-up with serial GCF sampling and standardized digital periapical radiography.
详细描述
Apical periodontitis healing is evaluated by clinical and radiographic follow-up, but radiographic interpretation may remain uncertain during the healing period. Gingival crevicular fluid is a minimally invasive oral biofluid that may reflect local inflammatory and bone remodeling changes associated with apical disease and recovery after treatment. The study will enroll adult patients undergoing primary nonsurgical root canal treatment for asymptomatic apical periodontitis. GCF will be sampled at baseline, 3 months, 6 months, and 12 months. OPG, L10, IL8 , CxCL10and RANKL concentrations will be measured by ELISA and the RANKL/OPG ratio calculated. Standardized digital periapical radiographs will be obtained at baseline ,6 months, and 12 months. The primary analysis will assess whether early changes in GCF biomarkers are associated with 12-month radiographic healing, quantified by lesion-area reduction and periapical index change.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 -40 years .
- •Presence of one permanent tooth diagnosed with asymptomatic apical periodontitis.
- •Diagnosis confirmed by pulp necrosis or non-vital pulp and presence of a periapical radiolucency on digital periapical radiograph.
- •Tooth indicated for primary nonsurgical root canal treatment.
- •Tooth must be restorable and periodontally healthy.
- •Periapical lesion detectable radiographically and suitable for follow-up evaluation.
- •Participant able and willing to provide written informed consent.
- •Participant willing to attend follow-up visits during the study period.
排除标准
- •Participants will be excluded if any of the following conditions are present:
- •Teeth previously treated with root canal treatment (retreatment cases).
- •Teeth with acute apical abscess, swelling, or sinus tract.
- •Teeth with combined endodontic-periodontal lesions.
- •Periodontal pockets >3 mm or evidence of active periodontal disease around the study tooth.
- •Teeth with vertical root fracture, root perforation, or severe root resorption.
- •Teeth with hopeless restorative or periodontal prognosis.
- •Patients with systemic diseases that may affect healing (e.g., uncontrolled diabetes, immunosuppression).
- •Pregnant or breastfeeding women.
- •Patients currently taking systemic antibiotics, corticosteroids, or anti-inflammatory medications within the last 2 weeks.
- •Current smokers or tobacco users.
- •Inability to attend scheduled follow-up visits.
研究组 & 干预措施
Asymptomatic Apical Periodontitis Treated with Root Canal Treatment
Adult patients with teeth diagnosed with asymptomatic apical periodontitis undergoing standardized primary nonsurgical root canal treatment. Gingival crevicular fluid biomarkers will be collected at baseline and follow-up visits and correlated with radiographic healing assessed by digital periapical radiography.
干预措施: Primary Nonsurgical Root Canal Treatment (Procedure)
结局指标
主要结局
Radiographic Healing of Apical Periodontitis
时间窗: 12 months after root canal treatment
次要结局
- Change in Gingival Crevicular Fluid biomarkers(Baseline, 3 months, 6 months ,and 12 months after root canal treatment)
研究者
Maha Adel
Assistant professor of Endodontics
Faculty of Dental Medicine for Girls