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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Periapical Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Neem leaf extract

Neem leaf extract (alcoholic solution) used as an anti inflammatory , antibacterial irrigant

Group Type EXPERIMENTAL

Neem leaf extract

Intervention Type DRUG

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

Chlorhexidine gluconate

2% chlorhexidine gluconate intracanal irrigant solution used as an antibacterial chemical mean for canal irrigation

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate

Intervention Type DRUG

2%chlorhexidine gluconate , anti bacterial root canal irrigant solution

Interventions

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Neem leaf extract

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

Intervention Type DRUG

Chlorhexidine gluconate

2%chlorhexidine gluconate , anti bacterial root canal irrigant solution

Intervention Type DRUG

Other Intervention Names

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Gluconate-Chex 2%

Eligibility Criteria

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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).

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes