Comparative Evaluation of Mineral Trioxide Aggregate, Ferric Sulfate and a 2 % Chitosan Hydrogel for Primary Molar Pulpotomy: An 18- Month Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Overall Treatment Success
研究概览
简要总结
Comparative Evaluation of Mineral Trioxide Aggregate (MTA), Ferric Sulfate, and Chitosan Hydrogel for Primary Molar Pulpotomy: An 18-Month Randomized Controlled Trial
Why is this study being done? When a child's tooth has a deep cavity, the decay can reach the soft inner part of the tooth called the pulp. A common treatment is called a pulpotomy - the dentist removes the infected part of the pulp and places a special material to protect the healthy root and save the tooth. Several materials are used for this treatment, but dentists do not yet agree on which one works best. This study compares three materials: (1) Mineral Trioxide Aggregate (MTA) - a well-known dental cement; (2) Ferric Sulfate (FS) - a liquid that stops bleeding; and (3) Chitosan Hydrogel - a new, natural gel made from shellfish shells. The goal is to find out which material keeps the treated tooth healthy for the longest time.
Who can take part? Healthy children aged 5 to 8 years who have at least one baby back tooth (primary molar) that needs a pulpotomy treatment may be eligible. Children with tooth pain, swelling, infection, or teeth that are too damaged will not be included. A parent or guardian must give written permission for their child to join the study.
What will happen during the study? 165 children will join the study and be randomly placed (like a coin toss) into one of three groups - each group receives a different pulpotomy material. The treatment is a routine pulpotomy done under local anesthesia (numbing injection) by an experienced pediatric dentist. After the pulpotomy material is placed, the tooth is sealed with a protective metal crown. Children will have check-up visits at 3, 6, 12, and 18 months. At each visit, the dentist checks the tooth by examination and by taking a small X-ray.
What are the possible risks? The risks are similar to those of any routine pulpotomy. Some children may feel mild soreness for 1 to 2 days after treatment. All three materials used in this study have been used in previous dental research. Children with shellfish allergies will be screened before enrollment.
What are the possible benefits? Participating children receive free professional dental treatment and regular check-ups at no cost for 18 months. The treatment aims to save the child's baby tooth, helping with chewing, speech, and guiding permanent teeth into the right position. The results of this study will help dentists choose the best treatment for children's teeth.
Is participation voluntary? Yes. Joining this study is completely voluntary. Parents and children may choose not to participate or may withdraw at any time without any effect on their future dental care. If a family does not join or decides to leave, their child will still receive standard dental treatment.
How is my child's information kept private? All information collected during this study is kept strictly confidential. Children's names are replaced with codes. Only the research team can access identifiable information. Results will be published in a way that does not identify any individual child.
详细描述
Detailed Description
- Background and Rationale Dental caries in primary molars frequently progresses to pulp involvement, necessitating pulpotomy - the surgical removal of infected coronal pulp tissue while preserving radicular vitality and function. Despite the availability of numerous pulpotomy medicaments, no consensus exists on the optimal agent, and comparative long-term data remain limited.
Mineral trioxide aggregate (MTA) is a calcium-silicate cement recognized for its biocompatibility and bioactivity. Upon setting, MTA releases calcium and hydroxyl ions, creating an alkaline, antibacterial microenvironment that promotes dentinal bridge formation and radicular pulp preservation. Its major practical drawbacks are high material cost and handling difficulties, which limit universal adoption in pediatric clinical settings.
Ferric sulfate (FS) is an inexpensive hemostatic agent that acts by forming ferric ion-protein complexes at the pulp stump surface, mechanically arresting hemorrhage. Unlike MTA, FS provides no bioactive stimulation of healing tissue. Histological investigations have demonstrated that FS-induced protein complexes can penetrate radicular pulp tissue over time, triggering persistent chronic inflammation and contributing to pathological internal root resorption - a recognized long-term liability.
Chitosan is a naturally derived polysaccharide obtained by deacetylation of chitin from crustacean exoskeletons. It holds FDA approval for topical hemostatic and antimicrobial medical applications. Its relevant biological properties include intrinsic hemostatic capacity (through platelet activation and erythrocyte aggregation), broad-spectrum antimicrobial activity, biocompatibility, and biodegradability. In vitro data further suggest chitosan may promote fibroblast proliferation and angiogenesis, raising the possibility of active pulpal healing rather than mere hemostasis. However, clinical evidence supporting its use as a pulpotomy medicament in primary teeth is restricted to short-term studies (6-12 months) with small sample sizes. No randomized controlled trial has previously compared chitosan against both MTA and FS with simultaneous clinical and radiographic success criteria over an 18-month period. This trial is designed to address that evidence gap. 2. Study Objectives The primary objective is to compare the 18-month overall success rate - defined as simultaneous clinical and radiographic success - of MTA, FS, and a 2% chitosan hydrogel when used as pulpotomy medicaments in primary molars, and to test the null hypothesis that no statistically significant difference in outcome exists among the three materials.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-8 years
- •At least one carious primary molar requiring pulpotomy treatment
- •Vital pulp confirmed at the exposure site after caries removal
- •Tooth restorable with a stainless-steel crown
- •Parent or legal guardian willing and able to provide written informed consent
排除标准
- •Non-vital pulp (no bleeding after pulp amputation)
- •History of spontaneous pain (suggesting irreversible pulpitis)
- •Presence of soft tissue swelling or sinus tract related to the target tooth
- •Pathological tooth mobility
- •Radiographic evidence of:
- •Internal or external pathological root resorption
- •Furcation or periapical radiolucency
- •More than one-third physiological root resorption
- •Any condition preventing successful stainless-steel crown placement (e.g. Insufficient coronal tooth structure)
研究组 & 干预措施
15.5% Ferric Sulfate Solution (Astringedent®) Arm
Participants in this arm received a single pulpotomy treatment using 15.5% ferric sulfate solution (Astringedent®, Ultradent) as the hemostatic and pulpotomy medicament. After standardized coronal pulp amputation and initial hemostasis (saline-moistened cotton pellet for up to 5 minutes), the ferric sulfate solution was applied directly onto the pulp stumps using a microbrush for 15 seconds, then thoroughly rinsed with sterile saline. No additional bioactive capping material was placed directly over the pulp. Over the treated pulp stumps, a layer of reinforced zinc-oxide eugenol (IRM, Dentsply) was placed as a base. The tooth was then restored with a reinforced glass ionomer base (Fuji IX GP) and a preformed stainless-steel crown. The intervention was administered once at baseline (day of pulpotomy), with no re-application of ferric sulfate during follow-up.
干预措施: Ferric Sulfate (Drug)
White ProRoot® Mineral Trioxide Aggregate (MTA)
Participants in this arm received a single pulpotomy treatment using White ProRoot® MTA (Dentsply, Maillefer, Tulsa Dental Specialties, Switzerland) as the pulpotomy medicament. After standardized coronal pulp amputation and hemostasis (saline-moistened cotton pellet for up to 5 minutes), the MTA powder was mixed with sterile water according to the manufacturer's instructions to form a putty-like consistency. The mixed MTA was then placed as a 2-3 mm thick layer directly onto the pulp stumps and gently condensed. No rinsing was performed. The material was allowed to set in the moist environment of the pulp chamber. Over the set MTA, a reinforced glass ionomer base (Fuji IX GP) was placed, followed by a preformed stainless-steel crown. The intervention was administered once at baseline (day of pulpotomy), with no re-application of MTA during follow-up.
干预措施: MTA (Drug)
2% Chitosan Hydrogel Arm
Participants in this arm received a single pulpotomy treatment using a 2% (w/v) chitosan hydrogel as the medicament. The chitosan powder (85% deacetylated, 300-350 kDa) was dissolved in 1% acetic acid, neutralized to pH 7.0, and sterilized by gamma irradiation (25-30 kGy), yielding a hydrogel with viscosity of approximately 850 cP. After standardized coronal pulp amputation and hemostasis (saline-moistened cotton pellet for up to 5 minutes), the sterile hydrogel was applied 2-3 mm thick directly onto the pulp stumps using a syringe. No additional hemostatic or capping agent was placed over the hydrogel. The tooth was then restored with a reinforced glass ionomer base (Fuji IX GP) and a preformed stainless-steel crown. No re-application or repeat intervention was performed. The intervention was administered once at baseline (day of pulpotomy), with no further chitosan applications during follow-up.
干预措施: 2% Chitosan Hydrogel (Device)
结局指标
主要结局
Overall Treatment Success
时间窗: 18 months post-pulpotomy
Overall success is defined as the simultaneous presence of clinical success AND radiographic success at the 18-month follow-up visit. Clinical success requires ALL of the following: No spontaneous pain reported by the child or parent No tenderness to percussion No soft tissue swelling or sinus tract No pathological tooth mobility (beyond normal physiologic mobility for a primary tooth) Radiographic success requires ALL of the following on a periapical radiograph: No internal pathologic root resorption No external pathologic root resorption No furcation radiolucency No periapical radiolucency No widening of the periodontal ligament space beyond normal limits A tooth is classified as a failure if it lacks either clinical success or radiographic success (or both) at the 18-month time point. Teeth that fail at any earlier visit are recorded as failures from that time onward and counted as failures at 18 months (intention-to-treat principle)
次要结局
未报告次要终点
研究者
Samah Fadhil Mohamed-Ali
Principal Investigator, Lecturer in Pediatric Dentistry, College of Dentistry, Mustansiriyah University, Iraq
Al-Mustansiriyah University