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Comparative Evaluation of Three Different Pulpotomy Agents in Primary Molars

Al-Mustansiriyah University · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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chitosan
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 stud
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