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

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

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.

Study Overview

• Status: Completed
• Conditions: Periapical Abscess
• Intervention / Treatment: Drug: Neem leaf extract; Drug: Chlorhexidine gluconate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Pediatric dentistry and Public health department-Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Dalia M Moheb, Assoc Prof, Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university; Study Director: Norhan A El Dokky, Assoc Prof, Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university

Publications and helpful links

General Publications

• Dutta A, Kundabala M. Comparative anti-microbial efficacy of Azadirachta indica irrigant with standard endodontic irrigants: A preliminary study. J Conserv Dent. 2014 Mar;17(2):133-7. doi: 10.4103/0972-0707.128047.
• Ercan E, Ozekinci T, Atakul F, Gul K. Antibacterial activity of 2% chlorhexidine gluconate and 5.25% sodium hypochlorite in infected root canal: in vivo study. J Endod. 2004 Feb;30(2):84-7. doi: 10.1097/00004770-200402000-00005.
• Louwakul P, Prucksathamrongkul W. The effect of 2% chlorhexidine as root canal irrigant in pulpectomies of primary molars. Pediatr Dent. 2012 Nov-Dec;34(7):e192-6.
• Podar R, Kulkarni GP, Dadu SS, Singh S, Singh SH. In vivo antimicrobial efficacy of 6% Morinda citrifolia, Azadirachta indica, and 3% sodium hypochlorite as root canal irrigants. Eur J Dent. 2015 Oct-Dec;9(4):529-534. doi: 10.4103/1305-7456.172615.
• Ruiz-Esparza CL, Garrocho-Rangel A, Gonzalez-Amaro AM, Flores-Reyes H, Pozos-Guillen AJ. Reduction in bacterial loading using 2% chlorhexidine gluconate as an irrigant in pulpectomized primary teeth: a preliminary report. J Clin Pediatr Dent. 2011 Spring;35(3):265-70. doi: 10.17796/jcpd.35.3.y052311j23617837.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 25, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Suppuration; Jaw Diseases; Periapical Diseases; Periodontitis; Abscess; Periapical Periodontitis; Periapical Abscess; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: Chx_neemleaf

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