Evaluation of the Aloe Vera Anti-inflammatory Effect on Apical Periodontitis, Randomized Clinical Trial; In Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- To detect Aloe Vera effect on pro-inflammatory by detecting cytokine IL-β level
研究概览
简要总结
The goal of this clinical trial is to evaluation aloe vera as intracanal medication anti-inflammatory also inter-appointment pain incidence compared with calcium hydroxide. The main questions it aims to answer are:
Does aloe vera reduced pro-inflammatory cytokine (IL-1b)? Researchers will compare aloe vera to calcium hydroxide intra-canal medication to see if it works to modulate the inflammatory response in necrotic teeth with apical periodontitis.
Participants will:
Receive the intra-canal medications following root canal preparation for 14 days, periapical tissue fluid samples will be collected after access cavity preparation and 14days post medication placement.
Pre-operative pain level and 24h, 48h post medication placement will be recorded.
详细描述
After recording pre-operative pain level using 10-pont VAS, anesthetization, the caries lesion was removed and the tooth isolated with rubber dam (Sanctuary). The missing walls of the tooth was restored using composite resin to ensure proper isolation and seal. Then with sterile burs, access cavity preparation was done.
Patency was gained and the canal was flushed with 3ml of saline to remove any debris in the canal that will interfere with the paper points and ensure accurate electronic apex locator reading. Then working length was measured by K files using electronic apex locator for accuracy and confirmed with periapical radiograph.
The canal was then dried to the working length with paper points then the first sample (S1) was taken by 3 paper points depending on the size of the initial file extended beyond the apical foramen 1-2mm and left in place for 30 sec using digital stopwatch. The collected sample was placed in Eppendorf tube and stored at -20°C for further analysis following the ELISA manufacture instructions ( Elabscience® Human IL-1β(Interleukin 1 Beta) ELISA Kit).
Chemo-Mechanical preparation of the canal was done using rotary files and 5.25% sodium hypochlorite diluted 1:1. The canal was dried using paper points then filled with Aloe Vera, calcium hydroxide or no medication depending on the subjects grouping, giving that G1 (n=11) of no medication, G2 (n=11) filled with Ca(OH)₂ while G3 (n=11) filled with aloe vera paste. The access cavity was sealed using sterile teflon and 2mm of composite resin.
At 24h,48h post intra-canal medication placement, pain level was recorded. At the second visit 14 days postoperatively, the canal was flushed with saline to remove the ICM and dried using paper points then sample 2 (S2) was collected following the same procedures as S1 then master cone adjustment and obturation were done.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders.
- •Older than the age of 18 years.
- •Medically free patients.
- •Participants should be willing to commit for the entire period of the trial and agreed to sign the written informed consent after complete explanation of the study protocol.
- •Participants with single rooted necrotic teeth with apical periodontitis, symptomatic (Visual analogue scale "VAS" and pain on percussion) or Asymptomatic (Radiographic evidence of apical periodontitis).
排除标准
- •Presence of Allergic reaction.
- •Participants taking antibiotics or NSAIDs.
- •Severely curved root.
- •Endodontically treated teeth.
- •Teeth with open apices.
研究组 & 干预措施
First group (G1), negative control group
will not receive any intra-canal medication
second group (G2), Medication A, Calcium hydroxide
Calcium hydroxide (Metapaste)
干预措施: Calcium Hydroxide (Ca(OH)2) Intracanal Medication (Drug)
Group 3 (G3), medication B, Aloe vera
Aloe vera gel
干预措施: Aloe vera gel (Drug)
结局指标
主要结局
To detect Aloe Vera effect on pro-inflammatory by detecting cytokine IL-β level
时间窗: 14 days
Detected using ELISA
次要结局
- inter-appointment incidence of pain using VAS(24hours, 48hours post intracanal medication placement)
