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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Underg

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 Summary:

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 3 months. S: Randomised controlled trial.

Sponsor: Cairo University

Current Primary Outcome:

• Pain [ Time Frame: 3 months ]
  Patient reported pain and pain on percussion , binary
• Swelling [ Time Frame: 3 months ]
  Visual examination ,binary
• Mobility [ Time Frame: 3 months ]
  Mobility test ,binary

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Bacterial load [ Time Frame: 48 hours ]
  Bacteria on culture plates measuring unit CFU/ml
• Periapical pathosis [ Time Frame: 3 months ]
  Periapical radiograph , binary

Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: October 21, 2016
Date Started: November 2016
Date Completion: September 2017
Last Updated: October 24, 2016
Last Verified: October 2016