Clinical Research of the Effects of Photodynamic Therapy and Bioceramic Filling of Root Canals on the Healing of Periapical Lesions and the Occurence of Postoperative Pain After Endodontic Retreatment
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in volume of periapical lesion
研究概览
简要总结
The purpose is to investigate influence of bioceramic filling of the root canal and photodynamic therapy on periapical healing and development of postoperative pain after endodontic retreatment. Patients are divided into two main groups and each of the group is divided into two subgroups. Main groups are patients receiving photodynamic therapy and patients receiving passive ultrasonic irrigation. Each of the main group is divided by the root canal filling material on the AH+ group and BioRoot group.
详细描述
Clinical trial will be conducted in Dental clinic Zagreb. Patients will be chosen for this randomized prospective trials from the everyday patients referred by general dentist for endodontic retreatment. In the research will be included only patients with symptoms of chronic apical periodontitis and previous endodontic treatment. It includes teeth sensitive to palpation, percussion or visible sinus tract or swelling and asymptomatic inadequate endodontic filling. Patients that are immunocompromised, pregnant women, teeth with pocket depth bigger then 3mm, teeth with signs of vertical root fracture, teeth that are impossible to restore are excluded from research.
Every patient will be assigned to one group and one subgroup using "wheeldecide" programme. Patients will not be aware what group or subgroup they are assigned. endodontic retreatment will be conducted by one specialist in endodontics. Therapy is single visit retreatment.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with symptoms of periapical disease after endodontic treatment,
- •teeth sensitive to percussion and palpation,
- •teeth with present sinus tract and
- •asymptomatic teeth with radiologically inadequate root canal filling.
排除标准
- •Immunocompromised patients,
- •pregnancy,
- •teeth with signs of vertical root fracture,
- •teeth that can't be restored,
- •antibiotic usage within last month,
- •teeth with acute apical abscess
研究组 & 干预措施
PUI/AH+
This arm will only get PUI (passive ultrasound irrigation) in combination with AH+ epoxy based cement and guttapercha points.
干预措施: BioRoot (Drug)
PDT+/BIOROOT
Photodynamic therapy will bi conducted with diode laser (660nm, 100mW, 60 seconds) with toluidine at the end of chemomechanical preparation. Final root canal filling will be with BioRoot in combination with guttapercha points.
干预措施: BioRoot (Drug)
PUI/BIOROOT
This arm will only get PUI (passive ultrasound irrigation) with 2,5ml of 2,5% sodium hypochlorite, then 2ml of 15% EDTA which will be activated for 60seconds (EndoUltra MicroMega, France) and finally 2,5ml of 2,5% of sodium hypochlorite will be also activated for 30 seconds. Root canal filling in combination with BioRoot and guttapercha points.
干预措施: BioRoot (Drug)
PDT+/AH+
Photodynamic therapy will bi conducted with diode laser (660nm, 100mW, 60 seconds) with toluidine at the end of chemomechanical preparation. Final root canal filling will be with AH+ epoxy based cement in combination with guttapercha points.
干预措施: BioRoot (Drug)
结局指标
主要结局
Change in volume of periapical lesion
时间窗: 1 year
Volumetric change of size of periapical lesion depending of the root canal filling material and the use of photodynamic therapy at the end of chemomechanical preparation.
Level of postoperative pain after endodontic treatment
时间窗: 7 days day after day monitoring of the level of pain.
After endodontic treatment receives questionaire with day - by - day monitoring of the level of pain on the scale from 0 (no pain) to 10 (sever pain)
次要结局
未报告次要终点
研究者
BORIS PAZIN
DDM, SPECIALIST IN ENDODONTICS AND RESTORATIVE DENTISTRY
Akademicka Poliklinika Stomatologiczna