Antimicrobial Photodynamic Therapy in the Endodontic Treatment of Anterior Primary Teeth With Pulp Necrosis: A Randomized Controlled Clinical Trial With Microbiological Analysis and Blinded Assessment of Clinical and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Clinical evaluation.
研究概览
简要总结
This randomized controlled clinical trial evaluated the immediate reduction in intracanal microbial load and the short-term clinical and radiographic progression of anterior primary teeth with pulp necrosis after conventional endodontic treatment or antimicrobial photodynamic therapy (aPDT). Seven children aged 2 to 5 years contributed 20 eligible single-rooted anterior primary teeth. Teeth were randomized to conventional endodontic treatment (10 teeth) or aPDT (10 teeth). The primary outcome was intracanal microbial load before and immediately after the assigned first-session intervention. Clinical outcomes were assessed at 7 days, 1 month, and 3 months, and radiographic outcomes were assessed at 1 and 3 months.
详细描述
The tooth was the unit of randomization and analysis. Some participants contributed more than one eligible tooth and could have teeth allocated to both study arms. Each eligible tooth was independently randomized using opaque, sealed, sequentially numbered envelopes.
After coronal access and working-length determination, three sterile paper points were maintained in the root canal for 30 seconds to obtain the baseline microbiological sample (S1).
In the conventional-treatment arm, S1 collection was followed by chemomechanical preparation using K-files, 1% sodium hypochlorite, and Endo PTC. A second microbiological sample (S2) was then collected.
In the aPDT arm, S1 collection was followed by intracanal application of 0.005% methylene blue for 3 minutes. Irradiation was performed with a Therapy XT red laser in continuous-wave mode at 660 nm, with a mean radiant power of 100 mW, for 90 seconds, delivering a radiant energy of 9 J through an intracanal optical fiber. The canal was then irrigated with sterile saline, and S2 was collected. No chemomechanical preparation, instrumentation, or sodium hypochlorite irrigation was performed in the aPDT arm before S2 collection.
After S2 collection, teeth in both arms received UltraCal XS calcium hydroxide intracanal medication, a thin gutta-percha base, and provisional sealing with glass ionomer cement. After 7 days, the teeth were reopened, the intracanal medication was removed, the canals were irrigated with 1% sodium hypochlorite, and definitive root canal filling was performed using Guedes-Pinto iodoform paste. Restorative treatment was performed in a subsequent session.
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
- Single (Outcomes Assessor)
盲法说明
Single - Outcomes Assessor
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either sex, aged 2 to 5 years, in the primary dentition stage.
- •At least one restorable single-rooted anterior primary tooth with pulp necrosis caused by deep caries or dental trauma.
- •At least two-thirds of the root remaining.
- •Sufficient cooperation to allow safe clinical treatment.
- •No systemic antibiotic therapy during the previous 3 months.
- •Written informed consent provided by a parent or legal guardian.
排除标准
- •Root resorption involving two-thirds or more of the root.
- •Involvement of the permanent successor tooth crypt.
- •Tooth requiring immediate extraction or not amenable to endodontic treatment.
- •Compromised systemic health or uncontrolled chronic disease.
- •Recent antibiotic use capable of affecting microbiological results.
- •Noncooperative behavior that precluded safe clinical treatment.
研究组 & 干预措施
Conventional Endodontic Treatment
After baseline microbiological sampling, teeth underwent chemomechanical root canal preparation using K-files, 1% sodium hypochlorite, and Endo PTC. The immediate post-intervention microbiological sample was then collected. Calcium hydroxide medication and provisional sealing were placed, followed by definitive root canal filling after 7 days.
干预措施: Conventional Endodontic Treatment (Procedure)
Antimicrobial Photodynamic Therapy
After baseline microbiological sampling, teeth received intracanal 0.005% methylene blue for 3 minutes, followed by red-laser irradiation at 660 nm, 100 mW, for 90 seconds, delivering 9 J through an intracanal optical fiber. No chemomechanical preparation, instrumentation, or sodium hypochlorite irrigation was performed before the immediate post-intervention sample. Calcium hydroxide medication and provisional sealing were placed, followed by definitive root canal filling after 7 days. Conventional rescue treatment was planned if symptoms persisted or worsened.
干预措施: Antimicrobial Photodynamic Therapy (Procedure)
结局指标
主要结局
Clinical evaluation.
时间窗: 6 months
If the teeth doesn´t has any sympton like pain, fistula etc...
Change in Intracanal Microbial Load From Baseline to Immediately Post-intervention
时间窗: Baseline and immediately post-intervention on Day 0
Viable intracanal microorganisms were quantified as colony-forming units per milliliter and transformed to log10 CFU/mL. Samples were collected using three sterile paper points maintained in the root canal for 30 seconds. S1 was collected before the assigned intervention. S2 was collected after chemomechanical preparation in the conventional-treatment arm and immediately after aPDT in the experimental arm. Change was calculated as S2 minus S1; more negative values indicate a greater reduction in viable microbial load.
次要结局
- Microbiological evaluation(Before and after the treatment (same day))
- Radiographic evaluation(6 mounth)
- Number of Treated Teeth With Clinical Signs or Symptoms(7 days, 1 month, and 3 months)
- Number of Treated Teeth With a Periapical or Periradicular Lesion(1 month and 3 months.)
- Number of Treated Teeth Without Radiographic Worsening(1 month and 3 months)
- Number of Treated Teeth With Pathological Root Resorption(1 month and 3 months)
研究者
Sandra Kalil Bussadori
PhD
University of Nove de Julho