Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants

Necrotic Pulp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05289843
• Other study ID #: ENDO 3-7-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: July 2023

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Ayah Ta El Sayed, M.D.S
• Phone: 01221902479
• Email: ayahtarek94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp

Intervention

Other:
• Rosmarinus Officinallis
Root canal Irrigants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).