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Active Not Recruiting NCT07774806

Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth

Conditions: Molar-Incisor Hypomineralization (MIH)

Sex: All
Ages: 6 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Meire Coelho Ferreira

Location: Universidade Ceuma São Luís Maranhão

Summary

BRIEF SUMMARY The goal of this clinical trial is to learn whether two materials used during pulpotomy treatment can reduce pain after treatment in children with molar-incisor hypomineralization (MIH), deep tooth decay, and irreversible pulpitis in permanent molars. The main questions it aims to answer are: * Does the type of material used during pulpotomy affect pain after treatment? * Does the type of material affect pain when chewing during the first week after treatment? Researchers will compare Mineral Trioxide Aggregate (MTA) and CIMMO DTA® to determine whether one material provides better pain control after pulpotomy treatment. Participants will: * Attend a dental examination to confirm eligibility for the study. * Receive pulpotomy treatment on an affected permanent molar using either MTA or CIMMO DTA®. * Return for follow-up evaluations after treatment. * Record pain levels using a child-friendly pain scale during the first week after the procedure. The information collected in this study may help identify effective and accessible treatment options for children with MIH and irreversible pulpitis while preserving permanent teeth and reducing the need for more invasive procedures.

Eligibility Criteria

Inclusion Criteria: * Children aged 6 to 16 years. * Presence of at least one permanent first molar diagnosed with Molar-Incisor * Hypomineralization (MIH), according to the criteria established by the European Academy of Paediatric Dentistry (EAPD). * Deep carious lesion involving the inner third of dentin, confirmed clinically and radiographically. * Diagnosis of symptomatic or asymptomatic irreversible pulpitis based on clinical examination, patient history, and pulp sensibility tests. * Tooth considered restorable after completion of treatment. * Presence of vital pulp tissue confirmed by bleeding following coronal pulp removal. * Child and parent/legal guardian able to understand study procedures and comply with follow-up requirements. * Written informed consent obtained from the parent or legal guardian and assent obtained from the child when applicable. Exclusion Criteria: * Teeth presenting clinical or radiographic signs of pulp necrosis. * Presence of spontaneous swelling, abscess, sinus tract, cellulitis, or other signs of acute odontogenic infection. * Evidence of internal or external root resorption. * Presence of periapical or furcation radiolucency suggestive of endodontic pathology. * Teeth with advanced periodontal disease or pathological mobility. * Teeth with root fractures, crown-root fractures, or extensive structural destruction that precludes definitive restoration. * Teeth in which hemostasis cannot be achieved within the time established by the study protocol after coronal pulp removal. * Children with systemic diseases or medical conditions that may affect healing or interfere with study outcomes. * Current use of medications that may alter pain perception, inflammatory response, or tissue healing. * Previous endodontic treatment or pulp therapy performed on the study tooth. * Inability or unwillingness of the participant or parent/legal guardian to attend follow-up visits.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07774806). StuddyBuddy aggregates publicly available trial information.