NCT03312153

Brief Summary

The aim of this study is to compare the effect of Neem (azadirachta indica) and 2.5% sodium hypochlorite as root canal irrigants on the intensity of post-operative pain and the amount of endotoxins in necrotic teeth.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

October 12, 2017

Last Update Submit

July 22, 2019

Conditions

PainPostoperative PainPostoperative ComplicationsNecrosisPathologic Processes

Outcome Measures

Primary Outcomes (1)

  • post operative pain

    post-instrumentaion pain and post-instrumentation pain assessed with the Numerical Rating Pain Scale

    Up to 48 hours

Secondary Outcomes (1)

  • endotoxins

    6 hours

Study Arms (2)

Neem (Azadirachta indica)

EXPERIMENTAL

Neem (Azadirachta indica) (alcoholic solution) used as an anti inflammatory , antibacterial irrigant

Drug: Neem

2.5%sodium hypochlorite

ACTIVE COMPARATOR

2.5% sodium hypochlorite, anti-bacterial root canal irrigant solution

Drug: 2.5% sodium hypochlorite

Interventions

NeemDRUG

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

Also known as: Azadirachta indica
Neem (Azadirachta indica)
2.5% sodium hypochloriteDRUG

anti bacterial root canal irrigant solution

Also known as: 2.5% NaOCL
2.5%sodium hypochlorite

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mandibular molar teeth:
  • Diagnosed clinically with pulp necrosis.
  • Absence of spontaneous pain
  • Pain on palpation or tenderness to percussion.
  • Periradicular radiolucency or widening of periodontal membrane space. 2- Patients' acceptance to participate in the trial. 3- Patients who can understand NRS scale and can sign the informed consent.

You may not qualify if:

  • \. Primary teeth and permanent teeth with immature roots which require special endodontic treatment protocol that seeking for obtaining good apical seal, proper cleaning, shaping and obturation 2. Patients who have received antibiotics for the last 3 months before the study or any medication that could alter their perception of pain, inflammation and infection .
  • \. Teeth previously accessed or endodontically treated as they have low success rate .
  • \. Patients with diabetes, immune-compromising and immune-suppresion disease as the healing is much more slowly and more liable to infection .
  • \. Pregnant patients to avoid exposure to radiograph. Moreover, pain perception may be altered due to hormonal changes .
  • \. Teeth with deep pocket \>4 mm as it has poor prognosis and deep pockets are harbor area for infection which need specific surgical and periodontal treatment .
  • \. Teeth that could not be isolated with a rubber-dam or could not be restorable.
  • \. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption as it has poor prognosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

PainPain, PostoperativePostoperative ComplicationsNecrosisPathologic Processes

Interventions

neem oilSodium Hypochlorite

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium Compounds

Central Study Contacts

Nadia Saeed Hosny

CONTACT

01225188862nadiahosny@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
* The study will be double-blinded which are the patients and the assessor. * The participants will drag the envelop and will not know which irrigant they will be treated with to not affect their behavior and their responses to the subjective outcome measures. also, not provide biased assessment of the effectiveness of the intervention . * The study will be double-blinded which are the patients and the assessor. * The participants will drag the envelop and will not know which irrigant they will be treated with . * Assessors in the microbiology laboratory in Microbiology department, Faculty of Medicine, Cairo University also will be blinded during assessment of data of endotoxins will not know the treatment group of the patients.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nadia Hosny

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 17, 2017

Study Start

August 1, 2019

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

EG(1)