Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy

Study Overview
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Brief Summary
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The trial is to test the resolution of pain, swelling and other signs of periapical infection and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as root canal irrigant in Pulpectomy treatment for children.

Detailed Description
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To compare the effectiveness of neem leaf extract with that of Chlorhexidine gluconate when used as an intracanal irrigant in primary molar teeth indicated for pulpectomy treatment. P: children with primary necrotic molars indicated for pulpectomy I: Neem leaf extract (alcoholic solution). C: 2% chlorhexidine gluconate. O: Pain and swelling resolution. T:Over 12 months. S: Randomised controlled trial.

Official Title
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Resolution of Pain and Swelling After the Use of Neem Leaf Extract (Azadirachta Indica) Compared to Chlorhexidine Gluconate as an Intracanal Irrigant in Necrotic Primary Molar Teeth in Children Undergoing Pulpectomy Treatment: A Randomised Controlled Trial

Conditions
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Periapical Abscess

Intervention / Treatment
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* Drug: Neem leaf extract
* Drug: Chlorhexidine gluconate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient and parent cooperation. Absence of any systemic disease that would contraindicate pulp therapy. Non vital molar teeth presenting with an acute or chronic periapical infection as a result of pulp necrosis ( Periapical abscess ,a sinus tract formation as a sequelae ) Making sure the patient is not taking an antibiotic and has not taken it for the past 2 weeks. Absence of physiologic or pathologic root resorption that contraindicate pulp therapy. Restorable teeth Molars with at least two thirds of root remaining. Exclusion Criteria: Children with any condition that contraindicates pulp therapy will be excluded (rheumatic fever, infective endocarditis , leukemia , corticosteroid therapy and immunosuppressed children).

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neem leaf extract<br>Neem leaf extract (alcoholic solution) used as an anti inflammatory , antibacterial irrigant | Drug: Neem leaf extract<br>* A natural irrigant solution act as anti-inflammatory and anti bacterial<br>|
| Active Comparator: Chlorhexidine gluconate<br>2% chlorhexidine gluconate intracanal irrigant solution used as an antibacterial chemical mean for canal irrigation | Drug: Chlorhexidine gluconate<br>* 2%chlorhexidine gluconate , anti bacterial root canal irrigant solution<br>* Other names: Gluconate-Chex 2%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Patient reported pain and pain on percussion , binary | 1 year | 
| Swelling | Visual examination ,binary | 1 year | 
| Mobility | Mobility test ,binary | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial load | Bacteria on culture plates measuring unit CFU/ml | 48 hours | 
| Periapical pathosis | Periapical radiograph , binary | 1 year |