Different Treatment Modality in Necrotic Primary Molars

Primary Teeth Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Triple Antibiotic Paste and Calcium Hydroxide With Iodoform as Intra-canal Medications in Regenerative Treatment of Necrotic Primary Teeth Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190914
• Other study ID #: PED18-4D
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: November 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 20, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Regeneration
• Necrosis
• Primary Teeth

Intervention

Other:
• pulp regeneration for necrotic primary teeth
a pulp regeneration procedure will be applied for necrotic primary teeth with different intracanal medication compared to conventional pulpectomy used in treatment for necrotic primary teeth

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry- Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
dina darwish

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the blind outcome assessor will evaluate the clinical success at 6 and 12 years	12 months
Primary	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	the blind outcome assessor will evaluate the radio graphic success at 6 and 12 years	12 months