Different Treatment Modality in Necrotic Primary Molars

Not Applicable

Completed

• Conditions: Primary Teeth; Dental Pulp Regeneration

• Registration Number: NCT04190914
• Lead Sponsor: dina darwish

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Study Start: 2020-02-07
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-12-03
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of patients treated in the 3 groups and have a clinical success according to the checklist absence of pain, pain on percussion, mobility, clinical abscess or fistula	12 months	the blind outcome assessor will evaluate the clinical success at 6 and 12 years
number of patients treated in the 3 groups and have a radio graphic success according to the checklist absence of radiolucency, internal or external root resorption	12 months	the blind outcome assessor will evaluate the radio graphic success at 6 and 12 years

Trial Locations

Locations (1)

Faculty of Dentistry- Ain Shams University; 🇪🇬 Cairo, Egypt