Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cements: An in Vivo Study With CBCT
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Volumetric Periapical Healing
研究概览
简要总结
The goal of this clinical trial is to conduct an in vivo study that allows to compare the periapical healing process of 3 different sealing cements through CBCT, as well as implement the evaluation of these lesions through volumetric measurements to provide high-level scientific information and thus have the possibility of being applied in the clinical dental practice, in patients attending UNICOC dental clinics between 2023 and 2024. The main question it aims to answer is:
- Do bioceramic sealer promote faster periapical healing due to their better sealing capacity and high bio-compatibility?
- Are there no differences between endodontic sealers in terms of apical healing? If there is a comparison group: Researchers will compare Bio-C Sealer (Bioceramic sealer) Zinc-oxide eugenol sealer and AH-Plus epoxy resin sealer to evaluate periapical healing after a six months follow-up of conventional endodontic therapy.
Coronal permanent restoration must be performed no later than 15 days after endodontic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Patients aged 18 to 60
- •Patients systemically healthy (ASA I)
- •Patients that require endodontic therapy for single-rooted teeth with pulp necrosis and apical periodontitis (AP).
- •CBCT PAI periapical index score 3 or above, with no symptoms at the time of appointment.
排除标准
- •Exclusion criteria included other than ASA-1 classification
- •Patients with Perforated cortical plates at cbct analysis
- •Premature permanent teeth
- •Patients with Endodontic-periodontic lesions, dystrophic calcifications, more than 20° root curvature
- •Pregnancy or lactation
- •Root fracture cases
- •Use of analgesics within 12-24 hours root canal therapy and patients with endodontic abscess.
研究组 & 干预措施
Groupe 1: ZOE-based sealant
ZOE-based sealant (GROSS-MAN, PROQUIDENT, COL)
干预措施: Zinc-Oxide Eugenol Sealer (Drug)
Groupe 2: AH-Plus Epoxy Resin Sealer
Epoxy resin-based sealant (AH Plus, Dentsply DeTrey, Konstanz, Germany)
干预措施: AH-Plus Epoxy Resin Sealer (Drug)
Groupe 3: Bio-C Sealer
Bioceramic sealer (Bio-C Sealer, ANGELUS, BRA)
干预措施: Bio-C Sealer (Drug)
结局指标
主要结局
Volumetric Periapical Healing
时间窗: Six months follow-up
Changes of the three-dimensional volume of the periapical lesion of endodontic origin
次要结局
未报告次要终点
研究者
Nestor Raúl Rios Osorio
Dentistry, Specialization in Endodontics, Master in Sciences
Institucion Universitaria Colegios de Colombia