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

Primary Purpose

Periapical Abscess

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Neem leaf extract
Chlorhexidine gluconate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Abscess

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Pediatric dentistry and Public health department-Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neem leaf extract

Chlorhexidine gluconate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain
Patient reported pain and pain on percussion , binary
Swelling
Visual examination ,binary
Mobility
Mobility test ,binary

Secondary Outcome Measures

Bacterial load
Bacteria on culture plates measuring unit CFU/ml
Periapical pathosis
Periapical radiograph , binary

Full Information

First Posted
October 21, 2016
Last Updated
July 30, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02943759
Brief Title
Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy
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 Undergoing Pulpectomy Treatment: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Abscess

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neem leaf extract
Arm Type
Experimental
Arm Description
Neem leaf extract (alcoholic solution) used as an anti inflammatory , antibacterial irrigant
Arm Title
Chlorhexidine gluconate
Arm Type
Active Comparator
Arm Description
2% chlorhexidine gluconate intracanal irrigant solution used as an antibacterial chemical mean for canal irrigation
Intervention Type
Drug
Intervention Name(s)
Neem leaf extract
Intervention Description
A natural irrigant solution act as anti-inflammatory and anti bacterial
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Gluconate-Chex 2%
Intervention Description
2%chlorhexidine gluconate , anti bacterial root canal irrigant solution
Primary Outcome Measure Information:
Title
Pain
Description
Patient reported pain and pain on percussion , binary
Time Frame
1 year
Title
Swelling
Description
Visual examination ,binary
Time Frame
1 year
Title
Mobility
Description
Mobility test ,binary
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bacterial load
Description
Bacteria on culture plates measuring unit CFU/ml
Time Frame
48 hours
Title
Periapical pathosis
Description
Periapical radiograph , binary
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalia M Moheb, Assoc Prof
Organizational Affiliation
Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Norhan A El Dokky, Assoc Prof
Organizational Affiliation
Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university
Official's Role
Study Director
Facility Information:
Facility Name
Pediatric dentistry and Public health department-Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24778508
Citation
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.
Results Reference
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PubMed Identifier
14977302
Citation
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.
Results Reference
background
PubMed Identifier
23265154
Citation
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.
Results Reference
background
PubMed Identifier
26929692
Citation
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.
Results Reference
background
PubMed Identifier
21678668
Citation
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.
Results Reference
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Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy

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