Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Necrotic Pulp
• Intervention / Treatment: Other: Rosmarinus Officinallis

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayah Ta El Sayed, M.D.S; Phone Number: 002 01221902479; Email: ayahtarek94@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Systematically healthy patient (ASA I and II).
2. Age between 20 and 45 years with no sex predilection

3. 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)
4. Patients who can understand and interpret Numerical rating scale (NRS).
5. Patients' acceptance to participate in the trial

Exclusion Criteria:

• 1- Medically compromised patients having significant systemic disorders. (ASA III or IV).

  2- 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.

  4- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Rosmarinus officinals will be used as root canal irrigant in treating aysymptomatic mandibular premolars.	Other: Rosmarinus Officinallis; Root canal Irrigants
No Intervention: Control Group; Sodium Hypochlorite used as control in root canal irrigations in treating a asymptomatic mandibular premoalrs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracanal bacterial load change.	The intracanal bacterial load change is calculated through using colony forming units per milliliter test before and after root canal preparation.	First as a base line and after 15 minutes ( End of the chemo-mechanical preparation).

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Necrosis; Dental Pulp Necrosis
• Other Study ID Numbers: ENDO 3-7-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No