Back to resultsEffect of Epigallocatechin-3-Gallate Solution as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Necrotic Tooth
Primary Purpose
Necrotic Pulp
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epigallocatechin-3-gallate
sodium hypochlorite
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp focused on measuring Asymptomatic, Necrotic Mandibular premolar
Eligibility Criteria
The inclusion criteria: Systematically healthy patient (ASA I, II). Age between 18 and 45 years Male or female. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis. The exclusion criteria: Medically compromised patients having significant systemic disorders. (ASA III or IV). Teeth with: Immature roots Association with swelling or sinus tract. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Epigallocatechin-3-Gallate
sodium hypochlorite
Arm Description
20% Epigallocatechin-3-Gallate solution
2.5% sodium hypochlorite
Outcomes
Primary Outcome Measures
Postoperative pain
Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10
Secondary Outcome Measures
Amount of intracanal bacterial load reduction
The intracanal bacterial load reduction 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
NCT05988788
Brief Title
Effect of Epigallocatechin-3-Gallate Solution as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Necrotic Tooth
Official Title
Effect of Epigallocatechin-3-Gallate Solution Versus Sodium Hypochlorite as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Asymptomatic Necrotic Mandibular Premolars: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
October 2024 (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
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
clinically compare the intensity of post-operative pain and the amount of bacterial load reduction after using 20% Epigallocatechin-3-gallate solution during chemomechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.
Detailed Description
The patients will be randomly divided into 2 groups. Intervention group (20% epigallocatechin-3-gallate solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant).
Post-operative pain will be measured at 6, 12, 24 and 48 hours post-operatively. The pain will be recorded using the Numerical Rating Scale (NRS).
Amount of bacterial load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp
Keywords
Asymptomatic, Necrotic Mandibular premolar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epigallocatechin-3-Gallate
Arm Type
Experimental
Arm Description
20% Epigallocatechin-3-Gallate solution
Arm Title
sodium hypochlorite
Arm Type
Active Comparator
Arm Description
2.5% sodium hypochlorite
Intervention Type
Other
Intervention Name(s)
Epigallocatechin-3-gallate
Other Intervention Name(s)
green tea catechin
Intervention Description
to be used as a root canal irrigant
Intervention Type
Other
Intervention Name(s)
sodium hypochlorite
Intervention Description
to be used as a root canal irrigant
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10
Time Frame
Postoperative pain measured at 6, 12, 24, 48 hours after single visit treatment.
Secondary Outcome Measure Information:
Title
Amount of intracanal bacterial load reduction
Description
The intracanal bacterial load reduction 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
T0: preintervention, preinstrumentation after access cavity. T1: postinstrumentation up to 10 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The inclusion criteria:
Systematically healthy patient (ASA I, II).
Age between 18 and 45 years
Male or female.
Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis.
The exclusion criteria:
Medically compromised patients having significant systemic disorders. (ASA III or IV).
Teeth with:
Immature roots
Association with swelling or sinus tract.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rayan adlan, BDS
Phone
+201117801699
Email
rayan.elsadig@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rayan adlan
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Epigallocatechin-3-Gallate Solution as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Necrotic Tooth
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