Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth

NCT07774806 | Active Not Recruiting DMC

• 1 other identifier: 94665725.9.0000.5084
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Molar-Incisor Hypomineralization (MIH)

Keywords

Molar-incisor hypomineralization; dental caries; pulpitis; pulpotomy; randomized controlled trial

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

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

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

Study Arms (2)

Full Pulpotomy with MTA

PLACEBO COMPARATOR

Participants will receive full pulpotomy using Mineral Trioxide Aggregate (MTA) as the pulp-capping material.

Other: MTA group

Full Pulpotomy with CIMMO DTA®

ACTIVE COMPARATOR

Participants will receive full pulpotomy using CIMMO DTA® as the pulp-capping material.

Other: CIMMO DTA® group

Interventions

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.

Also known as: Mineral Trioxide Aggregate

Full Pulpotomy with MTA

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.

Full Pulpotomy with CIMMO DTA®

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meire Coelho Ferreira: lead
• Universidade Ceuma: collaborator

Study Sites (1)

Universidade Ceuma

São Luís, Maranhão, 65075-120, Brazil

Location

Related Publications (4)

• 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.

  PMID: 36579231 BACKGROUND

• 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.

  PMID: 35751744 BACKGROUND

• 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.

  PMID: 40906299 BACKGROUND

• 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.

  PMID: 21496652 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization; Dental Caries; Pulpitis

Interventions

mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Demineralization; Dental Pulp Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: August 19, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: Researchers must submit a written proposal describing the intended use of the data. Requests will be evaluated by the study investigators, and access will be granted only to projects consistent with ethical and scientific standards.

Locations

BR (1)