Adjunctive Oral Probiotics in Endodontic Retreatment: Effects on Postoperative Pain and RANKL/OPG Levels (RANKL/OPG)
The Effect of Systemic Administration of Probiotics and Intra-Canal Medications on Level of Nuclear Factor Kappa B Ligand, Osteoprotegerin and Postoperative Pain in Patients With Chronic Apical Periodontitis: (Randomized Controlled Clinical Trial)
研究概览
地位
条件
详细说明
Post-treatment chronic apical periodontitis is an inflammatory condition caused by persistent microbial infection within the root canal system, characterized by progressive periapical bone destruction mediated by host immune-inflammatory mechanisms. Root canal retreatment remains the treatment of choice for failed endodontic cases; however, postoperative pain and incomplete resolution of inflammatory mediators remain common concerns. Clinical evidence demonstrates that postoperative pain following endodontic retreatment is influenced by microbial persistence, host inflammatory response, and intracanal medication protocols.
The RANK/RANKL/OPG axis is a key regulator of osteoclastic activity and periapical bone resorption. Elevated RANKL levels and altered RANKL/OPG ratio are associated with active periapical bone destruction. Modulation of this pathway may improve healing outcomes. Recent studies suggest that probiotics can regulate immune response, reduce inflammatory cytokines, and decrease RANKL expression.
This randomized clinical trial includes patients diagnosed with previously root-filled teeth presenting with chronic apical periodontitis indicated for non-surgical retreatment.
Standardized retreatment procedures are performed under aseptic conditions. Periapical exudate samples collected for biochemical analysis of RANKL and OPG levels at predetermined time points. Postoperative pain is assessed to investigate whether systemic probiotic administration can act as a host-modulating adjunct in endodontic retreatment and improve both symptomatic and biological healing outcomes.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Cairo Governorate
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Cairo、Cairo Governorate、埃及、11566
- Faculty of dentistry, Ain shams university
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Previously treated failed single rooted teeth with chronic apical periodontitis.
- No use of antibiotic three months before treatment.
- Patients are free of any systemic disease.
- Positive patient acceptance for participation
Exclusion Criteria:
- Teeth that are badly broken down with difficult isolation.
- Signs of acute infection, root fracture, root surface caries, swellings or ankylosis
- Periodontally affected teeth with pockets deeper than 4mm.
- Pregnant or lactating woman.
- Patients who needs any prophylactic antibiotic.
- Patients with allergy to pollen.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Oral probiotics + Local Ca(OH)2 ICM
Following endodontic retreatment, calcium hydroxide placed as an intracanal medicament .
Participants receive Linex Adult® (oral probiotics: Lactobacillus acidophilus, Bifidobacterium animalis ), one capsule daily for 21 days.
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Linex Adult® is an oral probiotic formulation containing Lactobacillus acidophilus, Bifidobacterium animalis, It is administered as one capsule once daily for 21 days.
其他名称：
Intracanal medication kept for 21 days
其他名称：
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实验性的：Oral probiotics + Local Propolis ICM
Following endodontic retreatment, propolis placed as an intracanal medicament.
Participants receive Linex Adult® (oral probiotics: Lactobacillus acidophilus, Bifidobacterium animalis), one capsule daily for 21 days.
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Linex Adult® is an oral probiotic formulation containing Lactobacillus acidophilus, Bifidobacterium animalis, It is administered as one capsule once daily for 21 days.
其他名称：
Intracanal medication kept for 21 days
其他名称：
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实验性的：Oral probiotics + Empty canal
Following endodontic retreatment, the canal was left empty without intracanal medicament.
Participants received Linex Adult® (oral probiotics: Lactobacillus acidophilus, Bifidobacterium animalis), one capsule daily for 21 days.
|
Linex Adult® is an oral probiotic formulation containing Lactobacillus acidophilus, Bifidobacterium animalis, It is administered as one capsule once daily for 21 days.
其他名称：
Empty canal for 21 days
其他名称：
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有源比较器：Oral placebo + Local Ca(OH)2 ICM
Following endodontic retreatment, Ca(OH)2 was placed as an intracanal medicament.
Participants received placebo, one capsule daily for 21 days
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Intracanal medication kept for 21 days
其他名称：
Placebo capsule for 21 days
其他名称：
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有源比较器：Oral placebo+ Local propolis ICM
Following endodontic retreatment, propolis was placed as an intracanal medicament.
Participants received placebo, one capsule daily for 21 days
|
Intracanal medication kept for 21 days
其他名称：
Placebo capsule for 21 days
其他名称：
|
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安慰剂比较：Oral placebo + Empty canal
Following endodontic retreatment, the canal was left empty without intracanal medicament.
Participants received Linex Adult® (oral probiotics: Lactobacillus acidophilus, Bifidobacterium animalis), one capsule daily for 21 days.
|
Empty canal for 21 days
其他名称：
Placebo capsule for 21 days
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The effect on RANKL and OPG levels in teeth with chronic apical periodontitis.
大体时间：(S1) measured in the first visit Immediately post-instrumentation and before ICM placement or oral supplement administration. (S2) After 21 days, immediately after removal of ICM and before obturation.
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Level of RANKL and OPG measured with periapical samples (S1) and (S2) and analysed using ELISA test
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(S1) measured in the first visit Immediately post-instrumentation and before ICM placement or oral supplement administration. (S2) After 21 days, immediately after removal of ICM and before obturation.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The effect on postoperative pain.
大体时间：Inter-appointment pain: baseline (start of the first visit), 4, 12, 24, 48, and 72 hours, and Week 1 and Week 2 after the first visit. Post-obturation pain: baseline (start of the second visit), 4, 12, 24, 48, and 72 hours after obturation.
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Pain level measured using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain), to evaluate inter-appointment pain between the first and second retreatment visits and post-obturation pain after the second retreatment visit and root canal obturation.
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Inter-appointment pain: baseline (start of the first visit), 4, 12, 24, 48, and 72 hours, and Week 1 and Week 2 after the first visit. Post-obturation pain: baseline (start of the second visit), 4, 12, 24, 48, and 72 hours after obturation.
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合作者和调查者
调查人员
- 研究主任：Abeer A.Elhakim El Gendy, PHD, Professor of Endodontics、AinShams university
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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