Clinical and Radiographic Evaluation of Chitosan Versus Formocresol After Vital Pulpotomy of Primary Molars: a Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 3 months
研究概览
简要总结
The goal of this clinical trial is to evaluate whether Chitosan liquid will show similar clinical and radiographical success rate compared to Formocresol when used in vital pulp therapy in primary molars.
The main question it aims to answer is:
- Will Chitosan liquid, in comparison to Formocresol, show similar clinical outcomes in relation to presence/absence of post-operative pain, swelling, sinus and/or fistula formation when used in vital pulpotomy in primary molars?
- Will Chitosan liquid, in comparison to Formocresol, show similar radiographical outcomes in relation to presence/absence of furcal involvement, periapical lesion, pathological root resorption and/or widening of periodontal membrane space when used in vital pulpotomy in primary molars?
Following conventional pulpotomy procedure, the primary investigator will evaluate the effect of placing a cotton pellet damp with Chitosan liquid directly on radicular vital pulp compared to that of placing a cotton pellet damp with Formocresol on radicular vital pulp.
Primary teeth included in both arms of the study will be restored by zinc oxide and eugenol and covered by a stainless steel crown as final restoration.
The clinical trail will be followed up for 1 year. Clinical outcomes will be evaluated every 3 months. Radiographic outcomes will be evaluated every 6 months.
详细描述
The main goal of pulp therapy is to maintain the integrity and health of the teeth and their supporting tissues while ensuring the vitality of the pulp of a tooth affected by caries, traumatic injury, or other causes.
Formocresol is a favored medicament for pulp therapy due to its proven success as a fixative, disinfectant, and devitalizing agent. For the past 70 years, it has been the most popular agent for vital pulpotomy in deciduous teeth with a success rate between 70-98%. However, concerns were issued about the potential toxic, mutagenic and cytotoxic effects of formocresol use.
Chitosan is a polysaccharide obtained by alkaline de-acetylation of chitin which is a very common natural biopolymer that can be found in the exoskeleton of crustacea. Chitosan is extensively studied in medical and pharmaceutical fields due to its competitive biological properties like biocompatibility, nontoxicity, analgesic, antitumor, hemostatic, antimicrobial, and antioxidant effects that makes it very interesting to develop for application in dentistry
The aim of the study is to evaluate the clinical and radiographical efficacy of chitosan liquid as pulp medicament compared to formocresol in vital pulpotomy of lower deciduous molars.
In this clinical trial, the principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of the intervention groups. For both interventions, informed consent will be obtained from parents/guardians of the participating children.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy cooperative children with at least one deep carious mandibular primary molar indicated for vital pulpotomy.
- •In age range from 4 to 8 years old.
- •Both sexes will be included.
- •Patients with provoked pain.
- •Restorable teeth.
排除标准
- •Excessive haemorrhage that cannot be stopped by a damp cotton pellet after several minutes.
- •With congenital anomalies in teeth e.g., taurodontism, concrescence or fusion.
- •Patients who show allergic reaction to any material will be used in this trial.
- •Will not be able to stick to follow up protocol in the trial and refuse to give communication data.
- •Patient's guardians refuse to sign up an informed consent before participating in this trial.
研究组 & 干预措施
Pulpotomy using Chitosan
Chitosan is a natural cationic polysaccharide polymer obtained from chitin deacetylation. It is a linear biopolymer consisting of 2-amino-2-deoxy-β-D-glucose (60-100%) and 2-acetamino -2-deoxy-β-D-glucoside (0-50%) bound together by ß (1→4) bonds. It is biocompatible and has antibacterial, anti-inflammatory and hemostatic properties.
干预措施: Pulpotomy using Chitosan liquid (Procedure)
Pulpotomy using Formocresol
Buckley's formocresol is composed of 31% water base, 15% glycerin to prevent formaldehyde from polymerizing to paraformaldehyde, 19% formaldehyde as an alkylating agent, and 35% tricresol as a protein-coagulating phenolic substance. A 1:5 concentration of Buckley's formocresol is used in this trial.
干预措施: Pulpotomy using Formocresol (Procedure)
结局指标
主要结局
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 3 months
时间窗: Baseline and 3 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 6 months
时间窗: Baseline and 6 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 9 months
时间窗: Baseline and 9 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
Change from Baseline in regards to post-operative pain (spontaneous or on biting) at 12 months
时间窗: Baseline and 12 months
Asking the patient and/or guardian to report any pain history at that time frame and/or complaint of discomfort and pain clinically. Outcome measuring unit: Binary (present/absent)
次要结局
- Change from Baseline in regards to swelling at 3 months(Baseline and 3 months)
- Change from Baseline in regards to swelling at 6 months(Baseline and 6 months)
- Change from Baseline in regards to swelling at 9 months(Baseline and 9 months)
- Change from Baseline in regards to swelling at 12 months(Baseline and 12 months)
- Change from Baseline in regards to sinus or fistula at 3 months(Baseline and 3 months)
- Change from Baseline in regards to sinus or fistula at 6 months(Baseline and 6 months)
- Change from Baseline in regards to sinus or fistula at 9 months(Baseline and 9 months)
- Change from Baseline in regards to sinus or fistula at 12 months(Baseline and 12 months)
- Change from Baseline in regards to furcal lesion at 6 months using Furcation Involvement Scores(Baseline and 6 months)
- Change from Baseline in regards to furcal lesion at 12 months using Furcation Involvement Scores(Baseline and 12 months)
- Change from Baseline in regards to periapical lesion at 6 months(Baseline and 6 months)
- Change from Baseline in regards to periapical lesion at 12 months(Baseline and 12 months)
- Change from Baseline in regards to pathologic root resorption at 6 months(Baseline and 6 months)
- Change from Baseline in regards to pathologic root resorption at 12 months(Baseline and 12 months)
- Change from Baseline in regards to width of periodontal membrane space at 6 months(Baseline and 6 months)
- Change from Baseline in regards to width of periodontal membrane space at 12 months(Baseline and 12 months)
研究者
Reem Ibrahim Helmi
Principal Investigator
Cairo University