Comparative Evaluation of Three Different Pulpotomy Agents in Primary Molars

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.

Detailed Description 1. 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. Secondary objectives include estimating pairwise risk differences (RD), relative risks (RR), and odds ratios (OR) with Bonferroni correction applied across three comparisons (adjusted α = 0.0167), and documenting clinical and radiographic success rates at each intermediate follow-up interval (3, 6, 12, a Покажи пълното описание...

Inclusion Criteria: * 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 Exclusion Criteria: * 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)