Different Treatment Modality in Necrotic Primary Molars

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Primary Teeth, Dental Pulp Regeneration

Intervention / Treatment
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* Other: pulp regeneration for necrotic primary teeth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: necrotic primary molar treated with pulpectomy followed by SSC<br>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<br>* 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<br>* Other names: different treatment options for necrotic primary teeth;|
| Experimental: necrotic primary molar treated with regeneration using triple<br>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<br>* 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<br>* Other names: different treatment options for necrotic primary teeth;|
| Experimental: necrotic primary molar treated with regeneration using metape<br>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<br>* 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<br>* Other names: different treatment options for necrotic primary teeth;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triple antibiotic paste