Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth | NCT07774806 | Trialant

Active, not recruitingInterventionalNot ApplicableUpdated Aug 20, 2026

Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth

Postoperative Pain Following Total Pulpotomy With Two Repair Cements in Carious Hypomineralized Teeth With Irreversible Pulpitis: A Randomized Clinical Trial

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07774806
Lead Sponsor: Meire Coelho FerreiraOTHER
Overall Status: Active, not recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Last Update Posted: Aug 20, 2026Actual
Start Date: Apr 16, 2026Actual
Primary Completion Date: Aug 2029Estimated
Completion Date: Sep 2029Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Postoperative Pain Following Total Pulpotomy With Two Repair Cements in Carious Hypomineralized Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
Brief 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

The medical conditions and diseases this study investigates.

Molar-Incisor Hypomineralization (MIH)

Interventions

The treatments and procedures being evaluated in this study.

MTA group
CIMMO DTA® group

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Universidade Ceuma

São Luís, Maranhão 65075-120, Brazil

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Meire Coelho FerreiraOTHER
Collaborators

Similar Studies

Other registered studies that closely resemble this one.

Detailed Description

Molar-incisor hypomineralization (MIH) is a developmental enamel defect affecting one or more permanent first molars, frequently associated with affected incisors. The condition is characterized by qualitative defects in enamel mineralization, resulting in increased porosity, post-eruptive enamel breakdown, hypersensitivity, and a higher risk of rapid caries progression. These clinical characteristics often complicate restorative treatment and may lead to early pulpal involvement in affected teeth.

The management of deep carious lesions and pulp inflammation in MIH-affected teeth remains a clinical challenge. Due to structural alterations in enamel and dentin, these teeth may present increased sensitivity, difficulty achieving adequate anesthesia, and a greater likelihood of restorative failure. Consequently, preserving pulpal vitality while controlling symptoms is a priority in pediatric dental care.

In recent years, vital pulp therapy has gained increasing acceptance as a conservative treatment approach for permanent teeth diagnosed with pulp inflammation. Among these procedures, full pulpotomy has demonstrated favorable clinical and radiographic outcomes, even in cases previously considered candidates for conventional root canal treatment. This approach aims to maintain the vitality and function of the remaining radicular pulp tissue, supporting continued tooth preservation and reducing treatment complexity.

Calcium silicate-based biomaterials play a central role in the success of pulpotomy procedures because of their bioactivity, sealing ability, and capacity to stimulate hard tissue formation. Mineral Trioxide Aggregate (MTA) is considered a reference material for vital pulp therapy; however, its cost and handling characteristics may limit widespread use in some clinical settings. CIMMO DTA® is a calcium silicate-based material that has shown promising biological and physicochemical properties and may represent a more accessible alternative. Nevertheless, clinical evidence comparing its performance with established materials in teeth affected by MIH remains limited.

This randomized clinical trial was designed to contribute to the evidence base regarding the management of pulpally involved MIH-affected permanent molars. By evaluating postoperative outcomes following full pulpotomy performed with different calcium silicate-based materials, the study seeks to generate clinically relevant information that may support treatment decision-making and expand access to conservative therapeutic options for children and adolescents.

The results of this study may contribute to improving the management of MIH-related complications, reducing the burden of dental pain, supporting tooth preservation, and strengthening evidence-based approaches in pediatric dentistry and vital pulp therapy.