Different Treatment Modality in Necrotic Primary Molars

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Teeth; Dental Pulp Regeneration
• Intervention / Treatment: Other: pulp regeneration for necrotic primary teeth

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry- Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: necrotic primary molar treated with pulpectomy followed by SSC; 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	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; Other Names: different treatment options for necrotic primary teeth
EXPERIMENTAL: necrotic primary molar treated with regeneration using triple; 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	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; Other Names: different treatment options for necrotic primary teeth
EXPERIMENTAL: necrotic primary molar treated with regeneration using metape; 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	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; Other Names: different treatment options for necrotic primary teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: dina darwish
• Investigators: Principal Investigator: Dina D Abd-Elmoneam, masters, Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 7, 2020
• Primary Completion (ACTUAL): September 7, 2021
• Study Completion (ACTUAL): September 20, 2021

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (ACTUAL): December 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: triple antibiotic paste
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: PED18-4D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No