Pulpotomy in Hypominerlized Permanent Molars.

NCT07756216 | Active Not Recruiting

• 1 other identifier: 547/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Molar Hypomineralization

Outcome Measures

Primary Outcomes (1)

• Clinical and radiographic success after 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.

  6 and 12 months after treatment

Secondary Outcomes (1)

• Postoperative pain after pulpotomy

  One week after pulpotomy

Other Outcomes (2)

• Tooth survival

  12 months post pulpotomy

• Patient satisfaction following pulpotomy treatment

  6 and 12 months after treatment

Study Arms (1)

MIH-Affected Permanent Molars Receiving Stepwise Pulpotomy Treatment

EXPERIMENTAL

MIH affected molars will receive a stepwise vital pulp therapy approach. Partial pulpotomy will be performed initially, and if adequate hemostasis cannot be achieved, the procedure will be converted to full pulpotomy. A calcium silicate-based pulp capping material and definitive restoration will be placed following the pulpotomy procedure. Participants will be followed clinically and radiographically for treatment outcomes.

Procedure: Step wise pulpotomy

Interventions

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.

MIH-Affected Permanent Molars Receiving Stepwise Pulpotomy Treatment

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan university of science and Technology

Irbid, 3030, Jordan

Location

Related Links

• A publication by the principal investigator that investigate quality of life after pulpotomy and presents its advantage.

MeSH Terms

Conditions

Molar Hypomineralization

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

Study Officials

• Nessrin Taha, DClinDent, PhD

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professsor

Model Details: All participants will receive the same stepwise vital pulp therapy protocol. Partial pulpotomy will be performed as the initial treatment approach. If adequate hemostasis cannot be achieved following partial pulpotomy, the procedure will be converted to full pulpotomy. The final treatment provided will therefore depend on the pulpal response during the procedure. Participants will be followed prospectively to evaluate clinical and radiographic outcomes after treatment.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: December 21, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

JO (1)