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Status unknownNCT03312153Updated Jul 24, 2019

Effect of Neem and NaOCl on Postoperative Pain and Amount of Endotoxins

An interventional study of Neem and 2.5% sodium hypochlorite in Pain, Postoperative Pain and Postoperative Complications, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

According to the eligibility and exclusion criteria the patients will be selected and randomly divided into two groups. The operator N.S. will complete endodontic treatment of all cases in two visits as following:

  1. Anaesthetizing the tooth using inferior alveolar nerve block followed by buccal infiltration technique.
  2. Isolation the tooth with a rubber dam and disinfect the tooth using sterile swabs moistened with 30% H2O2 (v/v) for 30 seconds followed by 5.25% NaOCl for 30 seconds and 5% sodium thiosulphate for inactivation of the disinfecting agents .

  3. Performing access cavity preparation in two stage :

    1. The first stage: will be performed to allow removal of contamination which includes carious lesions and restoration using high speed sterile round bur and diamond stone.
    2. In second stage: before entering the pulp chamber, the access cavity will be disinfected .

  4. For endotoxins sampling, the first sample (S1):

    N.S. will take the sample by introducing a sterile paper point (size #15) into the full working length of the wider / largest canals or canals that show presence of the exudate.

  5. N.S. will place the sample in a sterile glass for further Enzyme-linked immunosorbent assay (ELISA).
  6. After the first sampling,Taking working length using electronic apex locator and then will be confirmed radio-graphically .
  7. Performing the biomechanical preparation for the two groups in a crown-down technique using ProTaper Next rotary system.
  8. Irrigation with 2mL of specified irrigation either 2.5% NaOCl or Neem irrigant will be performed each time instrument is changed with 30-gauge side-vented needles.
  9. After complete mechanical preparation, the root canals will be flushed using 5mL of sterile saline solution.

  10. Before the second sampling (S2):

    N.S. will irrigate the prepared root canal with 5 mL of 17% EDTA solution for 3 minutes followed by a final rinse with 5 mL of a sterile saline solution to remove smear layer. NS will seal the access cavity with temporary filling material.

  11. Scheduling the second appointment 1 week after the first appointment;. NS will irrigate the root canals with 5 mL of a sterile saline solution.
  12. N.S. will give the patients a pain diary to record the postoperative pain after 6,12,24 and 48h post-instrumentation.
  13. in second appointment: After master cone fit radiograph and selection of the master cone, all canals will be filled using cold lateral condensation technique with resin-based sealer.
  14. N.S. will give the patients another pain diary to record the postoperative pain after 6, 12, 24 and 48 hours post-obturation.
02

Conditions studied

  • Pain
  • Postoperative Pain
  • Postoperative Complications
  • Necrosis
  • Pathologic Processes
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1- 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.

Exclusion criteria

Exclusion Criteria:

  • 1. 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 .

    3. Teeth previously accessed or endodontically treated as they have low success rate .

    4. Patients with diabetes, immune-compromising and immune-suppresion disease as the healing is much more slowly and more liable to infection .

    5. Pregnant patients to avoid exposure to radiograph. Moreover, pain perception may be altered due to hormonal changes .

    6. 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 .

    7. Teeth that could not be isolated with a rubber-dam or could not be restorable.

    8. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption as it has poor prognosis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Neem (Azadirachta indica)

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

    Drug: Neem

  • Active comparator
    2.5%sodium hypochlorite

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

    Drug: 2.5% sodium hypochlorite

Interventions

06

What researchers measure

Primary outcomes

  1. post operative pain

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

    Time frame: Up to 48 hours

Secondary outcomes

  1. endotoxins

    The quantitative enzyme-linked immunosorbent assay (ELISA) is a plate-based assay technique and is considered highly sensitive and specific test for detection and quantifying of endotoxin in the root canals by using a commercial standard kit. The samples will be collected by the operator and will be stored at -80C so that all the samples would be processed at the same time by ELISA.

    Time frame: 6 hours

07

Study locations

1 site
  • Cairo University
    Giza, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2019; primary completion for Feb 2020, 6 months later.

Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's planned 6 months is below that.

Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2017
First posted
Oct 17, 2017
StartEst.
Aug 1, 2019
Primary completionEst.
Feb 2020
CompletionEst.
Mar 2020
Last update
Jul 24, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03312153
Lead sponsor
Cairo University
Responsible party
Nadia Saeed Hosny (Nadia Hosny, Cairo University) — Principal investigator
First posted
Oct 17, 2017
Start date
Aug 1, 2019 (estimated)
Primary completion
Feb 2020 (estimated)
Completion
Mar 2020 (estimated)
Last update
Jul 24, 2019

Study contacts

Nadia Saeed Hosny
Contact
nadiahosny@dentistry.cu.edu.eg
01225188862

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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