NCT03312153

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Neem	A natural irrigant solution act as anti-inflammatory and anti bacterial
DRUG	2.5% sodium hypochlorite	anti bacterial root canal irrigant solution

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-02-01
• Completion: 2020-03-01
• First posted: 2017-10-17
• Last updated: 2019-07-24

Locations

1 site across 1 country: Egypt