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

Periapical Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943759
• Other study ID #: Chx_neemleaf
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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).

Related Conditions & MeSH terms

• Periapical Abscess

Intervention

Drug:
• Neem leaf extract
A natural irrigant solution act as anti-inflammatory and anti bacterial
• Chlorhexidine gluconate
2%chlorhexidine gluconate , anti bacterial root canal irrigant solution

Locations

Country	Name	City	State
Egypt	Pediatric dentistry and Public health department-Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

Ercan E, Ozekinci T, Atakul F, Gül 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. — View Citation

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. — View Citation

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):529-34. doi: 10.4103/1305-7456.172615. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Patient reported pain and pain on percussion , binary	1 year
Primary	Swelling	Visual examination ,binary	1 year
Primary	Mobility	Mobility test ,binary	1 year
Secondary	Bacterial load	Bacteria on culture plates measuring unit CFU/ml	48 hours
Secondary	Periapical pathosis	Periapical radiograph , binary	1 year