Pulpotomy in Hypominerlized Permanent Molars.

N/AActive Not RecruitingNCT07756216

King Abdullah University Hospital50 enrolled

Overview

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.

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.

Study Type

Conditions

Molar Hypomineralization

Interventions

Step wise pulpotomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Jordan university of science and Technology

Irbid, Jordan

Outcomes

Primary Outcomes

Success of pulpotomy

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.

Time frame: 6 and 12 months after treatment

Secondary Outcomes

Postoperative pain 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.

Time frame: One week after pulpotomy

Data from ClinicalTrials.gov

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