Back to resultsRosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants
Primary Purpose
Necrotic Pulp
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rosmarinus Officinallis
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp
Eligibility Criteria
Inclusion Criteria:
- 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
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control Group
Arm Description
Rosmarinus officinals will be used as root canal irrigant in treating aysymptomatic mandibular premolars.
Sodium Hypochlorite used as control in root canal irrigations in treating a asymptomatic mandibular premoalrs.
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05289843
Brief Title
Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple (Participant , Investigator, Outcomes assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Rosmarinus officinals will be used as root canal irrigant in treating aysymptomatic mandibular premolars.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Sodium Hypochlorite used as control in root canal irrigations in treating a asymptomatic mandibular premoalrs.
Intervention Type
Other
Intervention Name(s)
Rosmarinus Officinallis
Intervention Description
Root canal Irrigants
Primary Outcome Measure Information:
Title
Postoperative pain after root canal treatment.
Description
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 .
Time Frame
Up to 48 hours postoperative.
Secondary Outcome Measure Information:
Title
Intracanal bacterial load change.
Description
The intracanal bacterial load change is calculated through using colony forming units per milliliter test before and after root canal preparation.
Time Frame
First as a base line and after 15 minutes ( End of the chemo-mechanical preparation).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayah Ta El Sayed, M.D.S
Phone
01221902479
Ext
002
Email
ayahtarek94@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants
We'll reach out to this number within 24 hrs