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.

NCT06929247 | Not Yet Recruiting

• 1 other identifier: 20230730
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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 primary molars with irreversible pulpitis. Design: Randomized controlled trial with 2-arm parallel groups. Participants: Healthy children aged 4-9 with specific inclusion/exclusion criteria. Outcomes: Primary (pain relief, absence of complications) and secondary (radiographic success).

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  by Visual analog scale from zero to ten. which zero is better outcome and ten is worse outcome

  after 24h , 1week, 3 months, 6 months ,9 months and 12 months

Secondary Outcomes (5)

• Pain on percussion

  after 24h , 1week, 3 months, 6 months ,9 months and 12 months

• Number of tooth with Swelling or fistula

  after 24h , 1week, 3 months, 6 months ,9 months and 12 months

• Mobility

  after 24h , 1week, 3 months, 6 months ,9 months and 12 months

• Radiolucency at the furcation or periapical area

  after 24h , 1week, 3 months, 6 months ,9 months and 12 months

• Internal or external root resorption

  after 24h , 1week, 3 months, 6 months ,9 months and 12 months

Study Arms (2)

Pulpotomy

EXPERIMENTAL

Pulpotomy using Neoputty Mineral Trioxide Aggregate

Procedure: Pulpotomy using Neoputty Mineral Trioxide Aggregate

pulpectomy

ACTIVE COMPARATOR

Single-visit pulpectomy using Metapex

Procedure: single visit pulpectomy using metapex

Interventions

Pulpotomy using Neoputty Mineral Trioxide Aggregate PROCEDURE

Pulpotomy (Test Group): Removal of coronal pulp followed by Neoputty MTA placement and restoration.

Also known as: MTA

Pulpotomy

single visit pulpectomy using metapex PROCEDURE

pulpectomy: removal of radicular pulp followed by metapex placement and final restoration

Also known as: calcium hydroxide with iodoform

pulpectomy

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• \. Clinical signs of pulpal infection, such as pathologic tooth mobility, parulis/fistula, or soft tissue swelling.
• \. Pre-operative periapical radiographs indicating furcal radiolucency extending more than half the distance from the furcation to the periapical area.
• \. Pre-operative periapical radiographs showing periapical radiolucency. 4. Pre-operative periapical radiographs indicating pathological root resorption.
• \. Signs of necrosis in pulp tissue post-deroofing, such as avascular or minimally bleeding pulp, or yellowish necrotic areas/purulent exudate.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Mohamed Nashaat Mohamed: lead

MeSH Terms

Interventions

Pemetrexed; Calcium Hydroxide; iodoform

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of trial participants or clinical investigators will not be possible due to evident differences between the two trial interventions. However, postoperative clinical outcomes will be assessed by an experienced pediatric dentist who is blinded to the treatment allocation, while the radiographic outcomes will be independently assessed by two different pediatric dentists.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecture

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 16, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04