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NCT Number: NCT07756216

Pulpotomy in Hypominerlized Permanent Molars.

The first permanent molars in children can sometimes develop a condition called molar-incisor hypomineralization (MIH), which affects the strength and quality of the tooth structure. These teeth are more prone to breakdown and tooth decay, which may lead to inflammation of the dental pulp (the living tissue inside the tooth).

This study aims to evaluate the effectiveness of vital pulp therapy, a treatment designed to preserve the health of the pulp and maintain the tooth's function. The goal is to save the pulp tissue and reduce the need for more complex treatments such as root canal therapy.

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This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan university of science and Technology

Irbid, 3030, Jordan

About this study

Molar-incisor hypomineralization (MIH) is a developmental enamel defect affecting permanent first molars and incisors. Affected molars are more vulnerable to post-eruptive enamel breakdown, dental caries progression, and subsequent pulpal inflammation. When caries progresses to involve the pulp, preserving pulp vitality through vital pulp therapy (VPT) may provide an alternative to root canal treatment, particularly in young patients.

Although partial and full pulpotomy have shown favorable outcomes in young permanent teeth with deep caries and pulp exposure, limited evidence is available regarding their effectiveness in teeth affected by MIH. MIH-affected teeth may have altered pulpal characteristics, including increased vascularity, inflammatory response, and sensitivity, which may influence the response to vital pulp therapy.

This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a stepwise pulpotomy approach in young permanent first molars affected by MIH with deep caries and pulp exposure. Eligible teeth will initially receive partial pulpotomy. If adequate hemostasis cannot be achieved following partial pulpotomy, treatment will be converted to full pulpotomy. A calcium silicate-based material will be used for pulp capping, followed by definitive restoration.

Clinical and patient-reported outcomes will be assessed, including postoperative pain, the need for emergency intervention, and signs or symptoms of treatment failure. Radiographic evaluation will be performed at 6 and 12 months using periapical radiographs, with additional imaging when indicated, to assess the presence of periapical or furcal pathology, root changes, and overall treatment success.

The study will also investigate potential factors associated with treatment outcomes, including patient and tooth characteristics, MIH severity, pulpotomy type performed (partial or full pulpotomy), and pulpal inflammatory markers such as matrix metalloproteinase-9 (MMP-9). The findings will contribute to understanding the effectiveness and predictability of vital pulp therapy for MIH-affected permanent molars with carious pulp exposure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • • The patient age <14 years old
  • Non -contributory medical history
  • Molar tooth affected with MIH as per EAPD diagnostic criteria (17).
  • Deep caries extending>= 2/3 of dentine or exposing the pulp on the radiograph
  • The tooth should give positive response to cold sensibility testing
  • Clinical diagnosis of reversible/irreversible pulpitis based on the symptoms and results of cold testing.
  • The tooth is restorable, probing pocket depth and mobility are within normal limits
  • No signs of pulpal necrosis including sinus tract or swelling

Exclusion criteria

  • • Medically compromised patient.
  • Non-restorable tooth.
  • Signs of pulpal necrosis including sinus tract or swelling.
  • Uncooperative children who could not be treated under local anesthesia.
  • No enough bleeding after the pulpotomy procedure.
  • Inability to achieve hemostasis within 8 min after the pulpotomy.

Treatment and study plan

Step wise pulpotomy

Procedure

The stepwise vital pulp therapy approach include : partial pulpotomy will be performed initially, and if adequate hemostasis cannot be achieved, the procedure will be converted to full pulpotomy to the level of the root canal orifices.

Primary outcomes

  1. Success of pulpotomy

    Time frame: 6 and 12 months after treatment

    Clinical and radiographic success will be assessed based on the presence or absence of signs and symptoms of treatment failure at follow-up visits. Clinical success will be defined as the absence of spontaneous pain, tenderness to percussion or palpation, swelling, sinus tract, abnormal mobility, or other clinical signs of pulpal or periapical disease. For teeth undergoing partial pulpotomy, continued positive response to pulp sensibility testing will also be considered a criterion for clinical success. Radiographic success will be defined as the absence of new pathological findings, including periapical or furcal radiolucency, root resorption, or other radiographic evidence of treatment failure on follow-up imaging.

Secondary outcomes

  1. Postoperative pain after pulpotomy

    Time frame: One week after pulpotomy

    Postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Participants or their parents/guardians will report pain intensity following the pulpotomy procedure. The pain scores will be used to evaluate the postoperative pain response after vital pulp therapy.

Other outcomes

  1. Tooth survival

    Time frame: 12 months post pulpotomy

    Tooth survival will be assessed by determining the percentage of treated teeth that remains present and functional during the follow-up period and without clinical symptoms regardless of the radiographic status. Survival will be defined as retention of the treated tooth without extraction during the study period.

  2. Patient satisfaction following pulpotomy treatment

    Time frame: 6 and 12 months after treatment

    Patient satisfaction will be assessed using a structured questionnaire evaluating the child's and/or parent's perception of the treatment outcome, postoperative experience, and overall acceptance of the treatment. Satisfaction will be recorded during follow-up visits.

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study title

Outcome of Pulpotomy in MIH Affected Teeth With Carious Pulp Exposure: A Prospective Clinical Study.

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 10, 2026
Registry last updated
Aug 12, 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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