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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorMohamed Nashaat Mohamed

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. Clinical signs of pulpal infection, such as pathologic tooth mobility, parulis/fistula, or soft tissue swelling.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulpotomy using Neoputty Mineral Trioxide Aggregate

    Procedure/Surgery

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

  • single visit pulpectomy using metapex

    Procedure/Surgery

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: PulpotomyExperimental treatment 1 intervention
Group B: pulpectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative pain

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

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

Secondary outcomes

1

Pain on percussion

Tapping the tooth with the blunt end of the mirror

Time frame
after 24h , 1week, 3 months, 6 months ,9 months and 12 months
2

Number of tooth with Swelling or fistula

Clinical examination

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

Mobility

Clinical examination

Time frame
after 24h , 1week, 3 months, 6 months ,9 months and 12 months
4

Radiolucency at the furcation or periapical area

Digital periapical intraoral radiograph

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohamed Nashaat Mohamed

Lead sponsor

Cairo University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: