Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants

NCT05289843 | Unknown DMC

• 1 other identifier: ENDO 3-7-2
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

To measure the Effect of Rosmarinus Officinalis versus 2.5%Sodium Hypochlorite as Root canal Irrigants on the Intensity of post-operative pain and Bacterial Reduction in asymptomatic necrotic Mandibular premolars.

Conditions

Necrotic Pulp

Outcome Measures

Primary Outcomes (1)

• Postoperative pain after root canal treatment.

  The patient is asked to grade his degree of pain on the Numerical Rating Scale (NRS) chart which is an 11 points scale consisting of numbers from 0 to 10, where zero reading represents no pain , 1-3 readings represent mild pain, 4-6 readings represent moderate pain. 7-10 readings represent severe pain .

  Up to 48 hours postoperative.

Secondary Outcomes (1)

• Intracanal bacterial load change.

  First as a base line and after 15 minutes ( End of the chemo-mechanical preparation).

Study Arms (2)

Experimental

EXPERIMENTAL

Rosmarinus officinals will be used as root canal irrigant in treating aysymptomatic mandibular premolars.

Other: Rosmarinus Officinallis

Control Group

NO INTERVENTION

Sodium Hypochlorite used as control in root canal irrigations in treating a asymptomatic mandibular premoalrs.

Interventions

Rosmarinus Officinallis OTHER

Root canal Irrigants

Experimental

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systematically healthy patient (ASA I and II).
• Age between 20 and 45 years with no sex predilection
• Mandibular permanent premolar teeth:
• Diagnosed clinically with pulp necrosis.
• Absence of spontaneous pain.
• Radiographic evidence of root and root canal.
• Slight widening in the periodontal membrane space or with periapical radiolucency.
• No response to cold pulp tester (ethyl chloride spray)
• Patients who can understand and interpret Numerical rating scale (NRS).
• Patients' acceptance to participate in the trial

You may not qualify if:

• Medically compromised patients having significant systemic disorders. (ASA III or IV).
• History of intolerance to NSAIDS. 3- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
• Pregnant women: Avoid radiation exposure, anesthesia, and medication. 5- Teeth with: i. Vital teeth. ii. Double canal mandibular premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
• v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
• Immature teeth.
• Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ayah Ta El Sayed, M.D.S

CONTACT

01221902479; ayahtarek94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant , Investigator, Outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator and Master degree student at faculty of dentistry , Cairo university

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 22, 2022
• Study Start: May 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-03