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Molar-Incisor Hypomineralization (MIH)DOR-PULPNCT07774806

Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth

A study testing MTA group and CIMMO DTA® group in people with Molar-Incisor Hypomineralization (MIH), run by Meire Coelho Ferreira at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
Molar-Incisor Hypomineralization (MIH)
What is being tested?
MTA group and CIMMO DTA® group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteBrazil
Study dates
16 Apr 2026to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Universidade Ceuma

    São Luís, Maranhão, 65075-120

Other trials in Brazil

About this study

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

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.

Read more

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.

Read the 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.

Being tested
MTA group, CIMMO DTA® group
Keywords
Molar-incisor hypomineralization, dental caries, pulpitis, pulpotomy, randomized controlled trial
Medical subject headings
Molar Hypomineralization, Dental Caries, Pulpitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MTA groupOther

    Also called Mineral Trioxide Aggregate

    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.

  • CIMMO DTA® groupOther

    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.

Study groups in NCT07774806
Study groupRoleWhat they receive
Full Pulpotomy with MTAPlacebo comparatorParticipants will receive full pulpotomy using Mineral Trioxide Aggregate (MTA) as the pulp-capping material.
Receives: Other: MTA group
Full Pulpotomy with CIMMO DTA®Active comparatorParticipants will receive full pulpotomy using CIMMO DTA® as the pulp-capping material.
Receives: Other: CIMMO DTA® group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start16 Apr 2026
  3. Primary completionAug 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a two-arm, parallel-group, randomized clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive full pulpotomy treatment using either Mineral Trioxide Aggregate (MTA) or CIMMO DTA® as the pulp-capping material. Participants will remain in their assigned treatment group throughout the study and will receive only the intervention allocated at randomization. The clinical procedures, follow-up schedule, postoperative assessments, and outcome evaluations will be standardized across both groups. Randomization will be performed using a computer-generated sequence with allocation concealment to ensure unbiased assignment. The study is designed to compare postoperative outcomes following full pulpotomy in permanent molars affected by molar-incisor hypomineralization (MIH), deep carious lesions, and irreversible pulpitis. Outcome assessments will be conducted during the postoperative follow-up period using standardized evaluation methods applied.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774806
Sponsor's protocol ID
94665725.9.0000.5084
Acronym
DOR-PULP
Status last verified
Aug 2026
First submitted
8 Jul 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in publications arising from this study will be made available upon reasonable request to qualified researchers. Shared data will include participant demographic information, baseline clinical characteristics, intervention allocation, and outcome measures. Data will be provided after publication of the primary study results and only after approval of a methodologically sound research proposal and execution of a data-sharing agreement that protects participant confidentiality.

Publications

  • Alnassar I, Altinawi MK, Rekab MS, Alzoubi H, Katbeh I. Evaluation of Bioceramic Putty in Pulpotomy of Immature Permanent Molars With Symptoms of Irreversible Pulpitis. Cureus. 2022 Nov 22;14(11):e31806. doi: 10.7759/cureus.31806. eCollection 2022 Nov.

    PubMed 36579231
  • Al-Batayneh OB, Abdelghani IM. Outcome of vital pulp therapy in deeply carious molars affected with molar incisor hypomineralisation (MIH) defects: a randomized clinical trial. Eur Arch Paediatr Dent. 2022 Aug;23(4):587-599. doi: 10.1007/s40368-022-00722-w. Epub 2022 Jun 25.

    PubMed 35751744
  • Gumuskaya Kilic I, Unver H, Kargul B, Akbeyaz Sivet E. The impact of methylphenidate on oral health parameters, salivary flow rate, and quality of life in children with attention-deficit/hyperactivity disorder: a cross-sectional study. Clin Oral Investig. 2025 Sep 4;29(9):440. doi: 10.1007/s00784-025-06528-6.

    PubMed 40906299
  • Aguilar P, Linsuwanont P. Vital pulp therapy in vital permanent teeth with cariously exposed pulp: a systematic review. J Endod. 2011 May;37(5):581-7. doi: 10.1016/j.joen.2010.12.004. Epub 2011 Mar 5.

    PubMed 21496652

Questions about this trial

What is this clinical trial studying?

A study testing MTA group and CIMMO DTA® group in people with Molar-Incisor Hypomineralization (MIH), run by Meire Coelho Ferreira at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07774806, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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