Back to results

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

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

NCT ID

NCT02943759

First Posted

October 21, 2016

Last Updated

July 30, 2019

Sponsor

Cairo University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

background

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

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs