PainNCT03312153
Effect of Neem and NaOCl on Postoperative Pain and Amount of Endotoxins
A study testing Neem and 2.5% sodium hypochlorite in people with Pain and Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative Pain, Postoperative Complications
- What is being tested?
- Neem and 2.5% sodium hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neem (Azadirachta Indica) Versus 2.5% Sodium Hypochlorite as Root Canal Irrigants on the Intensity of Post-operative Pain and Amount of Endotoxins in Necrotic Teeth
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:
- Anaesthetizing the tooth using inferior alveolar nerve block followed by buccal infiltration technique.
- 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 .
- Performing access cavity preparation in two stage :
- 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.
- In second stage: before entering the pulp chamber, the access cavity will be disinfected .
- 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.
- N.S. will place the sample in a sterile glass for further Enzyme-linked immunosorbent assay (ELISA).
- After the first sampling,Taking working length using electronic apex locator and then will be confirmed radio-graphically .
- Performing the biomechanical preparation for the two groups in a crown-down technique using ProTaper Next rotary system.
- 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.
- After complete mechanical preparation, the root canals will be flushed using 5mL of sterile saline solution.
- 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.
- Scheduling the second appointment 1 week after the first appointment;. NS will irrigate the root canals with 5 mL of a sterile saline solution.
- N.S. will give the patients a pain diary to record the postoperative pain after 6,12,24 and 48h post-instrumentation.
- 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.
- N.S. will give the patients another pain diary to record the postoperative pain after 6, 12, 24 and 48 hours post-obturation.
- Being tested
- Neem, 2.5% sodium hypochlorite
- Medical subject headings
- Pain, Pain, Postoperative, Postoperative Complications, Necrosis, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeemDrug
Also called Azadirachta indica
A natural irrigant solution act as anti-inflammatory and anti bacterial
2.5% sodium hypochloriteDrug
Also called 2.5% NaOCL
anti bacterial root canal irrigant solution
| Study group | Role | What they receive |
|---|---|---|
| Neem (Azadirachta indica) | Experimental | Neem (Azadirachta indica) (alcoholic solution) used as an anti inflammatory , antibacterial irrigant Receives: Drug: Neem |
| 2.5%sodium hypochlorite | Active comparator | 2.5% sodium hypochlorite, anti-bacterial root canal irrigant solution Receives: Drug: 2.5% sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
post-instrumentaion pain and post-instrumentation pain assessed with the Numerical Rating Pain Scale
Measured: 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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Aug 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Saeed Hosny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312153
- Sponsor's protocol ID
- Irrigants in endodontics
- Status last verified
- Jul 2019
- First submitted
- 12 Oct 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neem (Azadirachta Indica) Versus 2.5% Sodium Hypochlorite as Root Canal Irrigants on the Intensity of Post-operative Pain and Amount of Endotoxins in Necrotic Teeth
- ClinicalTrials.gov ID
- NCT03312153
- Acronym / sponsor ID
- Irrigants in endodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Anaesthetizing the tooth using inferior alveolar nerve block followed by buccal infiltration technique.
- 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 .
- Performing access cavity preparation in two stage :
- 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.
- In second stage: before entering the pulp chamber, the access cavity will be disinfected .
- 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.
- N.S. will place the sample in a sterile glass for further Enzyme-linked immunosorbent assay (ELISA).
- After the first sampling,Taking working length using electronic apex locator and then will be confirmed radio-graphically .
- Performing the biomechanical preparation for the two groups in a crown-down technique using ProTaper Next rotary system.
- 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.
- After complete mechanical preparation, the root canals will be flushed using 5mL of sterile saline solution.
- 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.
- Scheduling the second appointment 1 week after the first appointment;. NS will irrigate the root canals with 5 mL of a sterile saline solution.
- N.S. will give the patients a pain diary to record the postoperative pain after 6,12,24 and 48h post-instrumentation.
- 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.
- N.S. will give the patients another pain diary to record the postoperative pain after 6, 12, 24 and 48 hours post-obturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neem (Azadirachta indica) | Experimental | Drug: NeemNeem (Azadirachta indica) (alcoholic solution) used as an anti inflammatory , antibacterial irrigant |
| 2.5%sodium hypochlorite | Active comparator | Drug: 2.5% sodium hypochlorite2.5% sodium hypochlorite, anti-bacterial root canal irrigant solution |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1- Mandibular molar teeth:
Key exclusion criteria (7 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeemAlso: Azadirachta indicaA natural irrigant solution act as anti-inflammatory and anti bacterial | Drug | Neem (Azadirachta indica) |
| 2.5% sodium hypochloriteAlso: 2.5% NaOCLanti bacterial root canal irrigant solution | Drug | 2.5%sodium hypochlorite |
Primary outcome
post operative pain
Time frame: Up to 48 hours
post-instrumentaion pain and post-instrumentation pain assessed with the Numerical Rating Pain Scale
1 secondary outcome
endotoxins
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neem and 2.5% sodium hypochlorite in people with Pain and Postoperative Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Saeed Hosny (01225188862, nadiahosny@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.