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

Phase 2

Completed

• Conditions: Periapical Abscess
• Interventions: Drug: Neem leaf extract; Drug: Chlorhexidine gluconate

• Registration Number: NCT02943759
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-25
• Study Start: 2016-12-01
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neem leaf extract	Neem leaf extract	Neem leaf extract (alcoholic solution) used as an anti inflammatory , antibacterial irrigant
Chlorhexidine gluconate	Chlorhexidine gluconate	2% chlorhexidine gluconate intracanal irrigant solution used as an antibacterial chemical mean for canal irrigation

Primary Outcome Measures

Name	Time	Method
Pain	1 year	Patient reported pain and pain on percussion , binary
Swelling	1 year	Visual examination ,binary
Mobility	1 year	Mobility test ,binary

Secondary Outcome Measures

Name	Time	Method
Periapical pathosis	1 year	Periapical radiograph , binary
Bacterial load	48 hours	Bacteria on culture plates measuring unit CFU/ml

Trial Locations

Locations (1)

Pediatric dentistry and Public health department-Cairo University; 🇪🇬 Cairo, Egypt