NCT02943759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

October 21, 2016

Last Update Submit

July 30, 2019

Conditions

Periapical Abscess

Outcome Measures

Primary Outcomes (3)

  • Pain

    Patient reported pain and pain on percussion , binary

    1 year

  • Swelling

    Visual examination ,binary

    1 year

  • Mobility

    Mobility test ,binary

    1 year

Secondary Outcomes (2)

  • Bacterial load

    48 hours

  • Periapical pathosis

    1 year

Study Arms (2)

Neem leaf extract

EXPERIMENTAL

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

Drug: Neem leaf extract

Chlorhexidine gluconate

ACTIVE COMPARATOR

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

Drug: Chlorhexidine gluconate

Interventions

Neem leaf extractDRUG

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

Neem leaf extract
Chlorhexidine gluconateDRUG

2%chlorhexidine gluconate , anti bacterial root canal irrigant solution

Also known as: Gluconate-Chex 2%
Chlorhexidine gluconate

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with any condition that contraindicates pulp therapy will be excluded (rheumatic fever, infective endocarditis , leukemia , corticosteroid therapy and immunosuppressed children).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric dentistry and Public health department-Cairo University

Cairo, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 24778508BACKGROUND

  • 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.

    PMID: 14977302BACKGROUND

  • 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.

    PMID: 23265154BACKGROUND

  • 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.

    PMID: 26929692BACKGROUND

  • 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.

    PMID: 21678668BACKGROUND

MeSH Terms

Conditions

Periapical Abscess

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

AbscessSuppurationInfectionsPeriapical PeriodontitisPeriapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • Dalia M Moheb, Assoc Prof

    Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university

    STUDY DIRECTOR

  • Norhan A El Dokky, Assoc Prof

    Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 25, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)