Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols

Study Overview
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Brief Summary
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This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp

Detailed Description
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Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically

Official Title
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Clinical Evaluation of Calcium Hydroxide Mixed With Gingerols Versus Metapex in Treatment of Primary Teeth With Infected Necrotic Pulp

Conditions
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Primary Teeth, Pulp Necroses, Infected Pulp, Root Canal Treatment

Intervention / Treatment
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* Procedure: Ginge-Cal
* Procedure: Metapex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments. Parents signed the consent to participate in the study. Absence of any systemic disease, which would contraindicate pulp therapy. Child didn't have any history of a sensitive reaction to any component of used materials. Present half to two third of tooth root or more Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment. Exclusion Criteria: All that does not correspond to inclusion criteria.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 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
Interventional Model Description: Selected children will be divided randomly into 2 groups: Group 1: Ginge-Cal group: primary molars were filled with a creamy mixture of pulpectomy paste of Gingerols and Calcium Hydroxide. Group 2: Metapex group: primary molars were filled with a ready-made injectable creamy mixture pulpectomy paste of Metapex.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Ginge-Cal group:<br>primary molars were filled by creamy mixture pulpectomy paste of Gingerols and Calcium Hydroxide. | Procedure: Ginge-Cal<br>* Fill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal)<br>|
| Active Comparator: Group 2: Metapex group<br>primary molars were filled by a ready-made injectable creamy mixture pulpectomy paste of Metapex | Procedure: Metapex<br>* Fill the infected root canal of of primary teeth with Metapex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of primary teeth with control necrotic pulp by clinical examination | The primary outcome was evaluated using clinical evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Clinical success will be judged to have occurred when there are no reports of pain, abscess, fistula, or mobility inconsistent with chronological age. | Up to 18 months | 
| Percentage of primary teeth with control necrotic pulp by radiographic examination | The primary outcome was evaluated using Radiographic evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Radiographic success will be evidenced by a decrease or absence of periapical or furcation area radiolucency and pathological root resorption | Up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Dentistry, Pulpectomy, Infected Pulp, Necrotic Pulp, Gingerols, Calcium Hydroxide, Metapex, Ginge-Cal