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Search / Trial NCT06929247

Clinical and Radiographic Evaluation of Pulpotomy Using Neoputty MTA Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years.

Launched by MOHAMED NASHAAT MOHAMED · Apr 14, 2025

Trial Information

Current as of July 21, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for children aged 4 to 9 who have a painful condition called irreversible pulpitis, which affects their primary molars (the big teeth in the back). The researchers want to compare two methods: one called pulpotomy, where they keep part of the tooth's nerve and use a special material called Neoputty MTA to help it heal, and the other called pulpectomy, where they remove the nerve and fill the space with a material called Metapex. The goal is to see which treatment works better in relieving pain and preventing complications.

To be eligible for the trial, children must show signs of irreversible pulpitis, like ongoing tooth pain that doesn't go away and is made worse by hot or cold foods. They also need to have healthy pulp tissue that bleeds normally when examined. However, children with signs of severe infection or certain issues seen on X-rays won't be included. Parents should know that the trial is not yet recruiting participants, and if enrolled, their child will receive either treatment and be monitored to see how well it works over time.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Symptoms typical of irreversible pulpitis, such as spontaneous, unprovoked pain lasting from a few seconds to several hours prior to the dental visit, or pain exacerbated by hot and/or cold stimuli that lingers even after the stimuli are removed.
  • 2. Confirmation of tooth vitality post-deroofing the pulp chamber, indicated by the presence of uniformly reddish-pink vascular tissue (healthy pulp) upon visual inspection of pulpal hemorrhage.
  • 3. Confirmation of radicular pulp health post-coronal pulp amputation, demonstrated by achieving radicular pulp hemostasis within 8 minutes using a 5% sodium hypochlorite (NaOCl)-dampened cotton pellet.
  • 4. The primary molar must be restorable with a stainless-steel crown. 5. Any physiological root resorption present must be less than one-third of the normal root length.
  • Exclusion Criteria:
  • 1. Clinical signs of pulpal infection, such as pathologic tooth mobility, parulis/fistula, or soft tissue swelling.
  • 2. Pre-operative periapical radiographs indicating furcal radiolucency extending more than half the distance from the furcation to the periapical area.
  • 3. Pre-operative periapical radiographs showing periapical radiolucency. 4. Pre-operative periapical radiographs indicating pathological root resorption.
  • 5. Signs of necrosis in pulp tissue post-deroofing, such as avascular or minimally bleeding pulp, or yellowish necrotic areas/purulent exudate.
  • 6. Evidence of extensive radicular pulp inflammation post-coronal pulp amputation, indicated by bleeding that continues after 8 minutes of compression with a NaOCl-soaked cotton pellet.
  • 7. Parents unwilling to place full coverage crowns post-treatment. 8. If both primary molars in the quadrant are painful and the clinical diagnosis of irreversible pulpitis between the teeth is not sharply defined.

About Mohamed Nashaat Mohamed

Mohamed Nashaat Mohamed is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, he oversees the design, implementation, and management of clinical studies across various therapeutic areas. Leveraging a robust network of healthcare professionals and research institutions, Mohamed ensures that trials adhere to the highest ethical standards and regulatory compliance, while fostering collaboration and transparency throughout the research process. His expertise and leadership contribute to the successful development of new treatments that address unmet medical needs.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported