Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin or Sodium Hypochlorite

NCT04728386 | Unknown

• 1 other identifier: CU-ENDO-11-10-2020
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare the effect of 2% curcumin solution versus 2.5% sodium hypochlorite as irrigating solutions in necrotic mandibular molars in terms of postoperative pain and antibacterial effect.

Conditions

Necrotic Pulp

Outcome Measures

Primary Outcomes (3)

• postoperative pain at 8 hours

  recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows: * 0 = no pain. * 1-3= mild pain. * 4-6= moderate pain. * 7-10= severe pain. scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows: * 0 = no pain. * 1-3= mild pain. * 4-6= moderate pain. * 7-10=severe pain

  8 hours

• postoperative pain at 24 hours

  recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:

  24 hours

• postoperative pain at 48 hours

  recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:

  48 hours

Secondary Outcomes (1)

• antibacterial effect

  during treatment

Study Arms (2)

curcumin irrigant

EXPERIMENTAL

final flush root canal irrigation with 5 ml curcumin solution

Other: curcumin solution

sodium hypochlorite

EXPERIMENTAL

final flush root canal irrigation with 5 ml sodium hypochlorite

Other: sodium hypochlorite

Interventions

curcumin solution OTHER

2 % curcumin solution as root canal irrigant

curcumin irrigant

sodium hypochlorite OTHER

2.5% sodium hypochlorite solution as root canal irrigant

sodium hypochlorite

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient's age between 18-50 years.
• Male and female.
• Systemically healthy patients (ASA I or II).
• Mature mandibular molar teeth with: Necrotic pulps, normal periapical radiographic appearance and no intra-canal calcifications or internal resorptive lesions

You may not qualify if:

• Medically compromised patients having substantive functional limitations (ASA III or IV).
• Patients having two or more adjacent teeth requiring endodontic treatment.
• Patients who received antibiotic therapy within the last three months before treatment.
• Patients administered analgesics in the last 24 hours before treatment.
• Teeth with:
• Vital pulps.
• Immature apices.
• Acute periapical abscess, swellings and facial cellulitis.
• Periodontally hopeless (mobility grade II or III).
• Previous root canal treatment.
• Non-restorable coronal portion.
• TMJ problems, bruxism or traumatic occlusion.
• Inability to perceive the given instructions

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• Yilmaz K, Tufenkci P, Adiguzel M. The effects of QMix and EndoActivator on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Clin Oral Investig. 2019 Nov;23(11):4173-4180. doi: 10.1007/s00784-019-02856-6. Epub 2019 Feb 27.

  PMID: 30815731 BACKGROUND

• Sotomil JM, Munchow EA, Pankajakshan D, Spolnik KJ, Ferreira JA, Gregory RL, Bottino MC. Curcumin-A Natural Medicament for Root Canal Disinfection: Effects of Irrigation, Drug Release, and Photoactivation. J Endod. 2019 Nov;45(11):1371-1377. doi: 10.1016/j.joen.2019.08.004. Epub 2019 Sep 18.

  PMID: 31542283 BACKGROUND

• Purohit RN, Bhatt M, Purohit K, Acharya J, Kumar R, Garg R. Clinical and Radiological Evaluation of Turmeric Powder as a Pulpotomy Medicament in Primary Teeth: An in vivo Study. Int J Clin Pediatr Dent. 2017 Jan-Mar;10(1):37-40. doi: 10.5005/jp-journals-10005-1404. Epub 2017 Feb 27.

  PMID: 28377653 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• eman medhat

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

eman medhat

CONTACT

01276054444; emanmedhat10@gmail.com

maha nasr

CONTACT

01114367063; mahmouhaa87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post graduate student

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: January 28, 2021

Record last verified: 2021-01