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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943759

Enrollment

Registered

2016-10-25

Start date

2016-12-01

Completion date

2018-02-01

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Abscess

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.

Interventions

DRUGNeem leaf extract

A natural irrigant solution act as anti-inflammatory and anti bacterial

DRUGChlorhexidine gluconate

2%chlorhexidine gluconate , anti bacterial root canal irrigant solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 8 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Pain	1 year	Patient reported pain and pain on percussion , binary
Swelling	1 year	Visual examination ,binary
Mobility	1 year	Mobility test ,binary

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026