Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
Mohamed Nashaat Mohamed
Conditions:
Pulpitis - Irreversible
Eligibility:
All Genders
4-9 years
Phase:
NA
Brief Summary
itle: Evaluation of Pulpotomy using Neoputty MTA vs. Pulpectomy using Metapex in Children (4-9 years). Objective: Compare clinical and radiographic success of pulpotomy vs. pulpectomy for vital prima...
Detailed Description
Background and Rationale Treating irreversible pulpitis in primary molars is challenging due to complex root canal anatomy and rapid progression of pulp inflammation. Pulpectomy is the standard approa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06929247
Start Date
April 1 2025
End Date
April 1 2026
Last Update
April 16 2025
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