Clinical trial NCT02943759: Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Periapical Abscess
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pain
timeFrame: 1 year
measure: Swelling
timeFrame: 1 year
measure: Mobility
timeFrame: 1 year
Secondary outcomes:
measure: Bacterial load
timeFrame: 48 hours
measure: Periapical pathosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric dentistry and Public health department-Cairo University
Study officials:
affiliation: Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university
name: Dalia M Moheb, Assoc Prof
role: STUDY_DIRECTOR
affiliation: Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university
name: Norhan A El Dokky, Assoc Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.
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):529-534. doi: 10.4103/1305-7456.172615.
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. doi: 10.17796/jcpd.35.3.y052311j23617837.