Different Treatment Modality in Necrotic Primary Molars

dina darwish

Status: Completed

Conditions: Dental Pulp Regeneration; Primary Teeth

Treatments: Other: pulp regeneration for necrotic primary teeth

Study type: Interventional

Funder types: Other

Identifiers

NCT04190914

PED18-4D

Details and patient eligibility

About

Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.

Full description

A convenient sample of preschool children have a necrotic primary second molar randomly allocated to one of the 3 study groups which are: group A (control) treated by the conventional treatment ( pulpectomy followed by stainless steel crown SSC), group B: treated by regeneration using triple antibiotic paste followed by SSC), group 3:(treated by regeneration using calcium hydroxide with iodoform(metapex) followed by SSC.

the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic success.

Enrollment: 54 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A child with one or more necrotic primary teeth
• Presence of abscess/fistula
• Sensitivity to percussion
• Presence of maximum grade 2 mobility ( Not more than 1 mm)
• Increases of the dental lamina dura
• cooperative patients

Exclusion criteria

• Medically compromised children
• Patient allergic to any of the used materials
• Presence of pathologic root resorption (internal-external) or more than 1/3 of the apical root.
• Presence of vitality in the canals
• Presence of grade 3 mobility
• Non-restorable teeth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups

necrotic primary molar treated with pulpectomy followed by SSC

Active Comparator group

Description:

control group treated by pulpectomy under rubber dam isolation access cavity will be prepared by a round bur then filling and irrigation will be performed and the tooth will be restored with a temporary filling. After one week all signs and symptoms will be assessed in case of absence of signs and symptoms the tooth will be restored with zin oxide and eugenol and SSC

Treatment:

Other: pulp regeneration for necrotic primary teeth

necrotic primary molar treated with regeneration using triple

Experimental group

Description:

under rubber dam isolation access cavity will be prepared by a round bur then minimal filling and irrigation will be performed then triple antibiotic paste will be inserted into the canals and the tooth will be restored by a glass ionomer (GI) as a temporary filling. After2-4 weeks all signs and symptoms will be assessed in case of absence of signs and symptoms an endodontic file will be used to induce bleeding from the periapical area after hemostasis mineral trioxide aggregate will be applied followed by SSC

Treatment:

Other: pulp regeneration for necrotic primary teeth

necrotic primary molar treated with regeneration using metape

Experimental group

Description:

under rubber dam isolation access cavity will be prepared by a round bur then minimal filling and irrigation will be performed then calcium hydroxide with iodoform (metapex) will be inserted into the canals and the tooth will be restored by a glass ionomer (GI) as a temporary filling. After 2-4 weeks all signs and symptoms will be assessed in case of absence of signs and symptoms an endodontic file will be used to induce bleeding from the periapical area after hemostasis mineral trioxide aggregate will be applied followed by SSC

Treatment:

Other: pulp regeneration for necrotic primary teeth