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Active, not recruiting

NCT Number: NCT07774806

Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MTA group

Other

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 names: Mineral Trioxide Aggregate

CIMMO DTA® group

Other

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.

Primary outcomes

  1. Spontaneous Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale

    Time frame: 6 hours, 12 hours, 24 hours, and Days 2, 3, 4, 5, 6, and 7 after treatment.

    Spontaneous postoperative pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale, which consists of six facial expressions corresponding to scores from 0 to 5. A score of 0 indicates no pain, and a score of 5 indicates the worst possible pain. Higher scores indicate greater pain intensity and therefore a worse outcome. Participants will report their spontaneous postoperative pain without application of an external stimulus.

Secondary outcomes

  1. Stimulated Postoperative Pain Intensity During Biting Measured by the Wong-Baker FACES Pain Rating Scale

    Time frame: 6 hours, 12 hours, 24 hours, and Days 2, 3, 4, 5, 6, and 7 after treatment.

    Stimulated postoperative pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale during a standardized bite test. A latex device measuring 3 × 2 cm will be placed over the treated tooth, and participants will be instructed to bite the device for approximately 3 seconds. Immediately after reporting spontaneous postoperative pain, participants will report the pain experienced during biting using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions corresponding to scores from 0 to 5, with 0 indicating no pain and 5 indicating the worst possible pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

Sponsors and collaborators

Lead sponsor

Meire Coelho Ferreira

Other

Collaborators

  • Universidade Ceuma

Registry information

Official study title

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

Acronym: DOR-PULP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 19, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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