Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

Minia University

Status: Enrolling

Conditions: Post Operative Pain

Treatments: Other: Metapex; Other: Endoflas

Study type: Interventional

Funder types: Other

Identifiers

NCT05475795

576-2022

Details and patient eligibility

About

Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.

Full description

The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials

Enrollment: 150 estimated patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:

Clinical:

1. 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
2. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
3. Presence of at least one primary molar with deep carious lesion.
4. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.

Radiographic:

1. Extensive caries approaching to the pulp.
2. Presence of at least two-thirds of root length.

Exclusion criteria

• A child's tooth with any of the following criteria:

Clinical findings:

1. History of spontaneous unprovoked toothache.
2. Extensive crown destruction that preclude coronal restoration.
3. Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
4. History of administering analgesics 12 hours before tooth obturation.

Radiographic findings:

1. Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
2. Presence of pathological internal/external root resorption.
3. Absence of underlying permanent successor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Metapex group

Active Comparator group

Description:

Obturation of primary molars with calcium hydroxide and iodoform paste

Treatment:

Other: Endoflas

Other: Metapex

Endoflas group

Experimental group

Description:

Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste

Treatment:

Other: Endoflas

Other: Metapex