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Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth

NCT07774806 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

  • Molar-Incisor Hypomineralization (MIH)

Interventions

OTHER

MTA group

Participants will undergo full pulpotomy of a permanent molar affected by molar-incisor hypomineralization (MIH), deep carious lesion, and irreversible pulpitis. Following complete removal of the coronal pulp tissue and achievement of hemostasis, Mineral Trioxide Aggregate (MTA), a calcium silicate-based bioceramic material, will be placed directly over the remaining radicular pulp tissue according to the manufacturer's instructions. The tooth will subsequently receive definitive restoration following the standardized treatment protocol established for the study.

OTHER

CIMMO DTA® group

Participants will undergo full pulpotomy of a permanent molar affected by molar-incisor hypomineralization (MIH), deep carious lesion, and irreversible pulpitis. Following complete removal of the coronal pulp tissue and achievement of hemostasis, CIMMO DTA®, a calcium silicate-based bioactive cement, will be placed directly over the remaining radicular pulp tissue according to the manufacturer's instructions. The tooth will subsequently receive definitive restoration following the standardized treatment protocol established for the study.

Sponsors & Collaborators

  • Universidade Ceuma

    collaborator OTHER

  • Meire Coelho Ferreira

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-16
Primary Completion
2029-08-31
Completion
2029-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774806 on ClinicalTrials.gov