Back to resultsEffect of Moringa Oleifera Leaf Extract on Postoperative Pain and Bacterial Reduction in Mandibular Premolars
Primary Purpose
Necrotic Pulp
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Moringa oleifera leaf
Sodium hypochlorite
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp
Eligibility Criteria
Inclusion Criteria:
- Systematically healthy patient (ASA I,II).
- Age between 20 and 55 years
- Male or female.
- Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with apical periodontitis.
- Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.
Exclusion Criteria:
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
Teeth with:
- Immature roots
- Vital pulp tissues.
- Association with swelling.
- Acute peri-apical abscess or acute exacerbation of a chronic abscess.
- Mobility Grade II or III.
- Previously accessed or endodontically treated
- Deep periodontal pockets more than 4 mm
- Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
- Patients who could not interpret the NRS.
- Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Moringa oleifera
Sodium hypochlorite
Arm Description
Outcomes
Primary Outcome Measures
Postoperative pain
postoperative pain will be marked by the patient using the Numerical rating scale (NRS) chart which is an 11 point scale consisting of numbers from 0 through 10, where: 0: 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 will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05348824
Brief Title
Effect of Moringa Oleifera Leaf Extract on Postoperative Pain and Bacterial Reduction in Mandibular Premolars
Official Title
Effect of Moringa Oleifera Leaf Extract Versus Sodium Hypochlorite as Root Canal Irrigant on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 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
5. Study Description
Brief Summary
The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using Moringa oleifera leaf extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit
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
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moringa oleifera
Arm Type
Experimental
Arm Title
Sodium hypochlorite
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Moringa oleifera leaf
Intervention Description
Leaf extract preparation
Intervention Type
Drug
Intervention Name(s)
Sodium hypochlorite
Intervention Description
2.5% sodium hypochlorite (household bleaching agent)
Primary Outcome Measure Information:
Title
Postoperative pain
Description
postoperative pain will be marked by the patient using the Numerical rating scale (NRS) chart which is an 11 point scale consisting of numbers from 0 through 10, where: 0: 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 postoperatively
Secondary Outcome Measure Information:
Title
Intracanal bacterial load change
Description
The intracanal bacterial load change will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation.
Time Frame
First sample is taken at Time 0 "T0" then second sample taken after chemo-mechanical preparation on 15 minutes at Time 1 "T1".
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systematically healthy patient (ASA I,II).
Age between 20 and 55 years
Male or female.
Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with apical periodontitis.
Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.
Exclusion Criteria:
Medically compromised patients having significant systemic disorders. (ASA III or IV).
History of intolerance to NSAIDS.
Teeth with:
Immature roots
Vital pulp tissues.
Association with swelling.
Acute peri-apical abscess or acute exacerbation of a chronic abscess.
Mobility Grade II or III.
Previously accessed or endodontically treated
Deep periodontal pockets more than 4 mm
Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
Patients who could not interpret the NRS.
Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
12. IPD Sharing Statement
Learn more about this trial
Effect of Moringa Oleifera Leaf Extract on Postoperative Pain and Bacterial Reduction in Mandibular Premolars
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