Back to resultsEpigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Primary Purpose
Irreversible Pulpitis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Epigallocatechin gallate (EGCG)
Sodium hypochlorite (NaOCl)
Mineral trioxide aggregate (MTA)
Premixed bioceramic putty
Sponsored by
About this trial
This is an interventional treatment trial for Irreversible Pulpitis
Eligibility Criteria
Inclusion Criteria: Patients of either gender between the age group of 20-40 years. Systemically healthy patient (ASA I or II). Mature permanent mandibular molars with: Extremely deep carious lesion (caries penetrating entire thickness of dentin). Clinical diagnosis of symptomatic irreversible pulpitis and normal periapical tissue. Patients who agree to provide written consent and attend for recall appointments. Exclusion Criteria: Non-restorable teeth with subgingival caries or badly broken teeth. Signs of pulpal necrosis; associated sinus tract or swelling. Negative response to pulp sensibility test. Poor periodontal support. Absence of pulp exposure following complete caries removal. Bleeding from the pulp could not be detected from one or more of the orifices indicating pulp necrosis. Failure to achieve haemostasis within 10 min following full pulpotomy.
Sites / Locations
- Faculty of Dentistry, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
EGCG as a flushing fluid, MTA as a pulp capping material
EGCG as a flushing fluid, Premixed BC putty as a pulp capping material
NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material
NaOCl as a flushing fluid, MTA as a pulp capping material
Arm Description
Outcomes
Primary Outcome Measures
Postoperative pain
Pain assessments will be made at 24, 48, 72 hours and one week postoperatively using an 11-point NRS. Pain will be categorized into 4 categories as follows: 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
Clinical success
The outcome will be considered successful in case of absence of clinical signs and symptoms indicative of pulpal or periapical pathosis (pain and tenderness to percussion).
Radiographic success
The outcome will be considered successful in case of complete radiographic healing (PAI score 1 or 2) with absence of any pathosis on recall radiographs such as root resorption.
Dentin bridge thickness
CBCT scans will be performed at 12 months to measure the thickness of the dentin bridge formed at the interface between the pulp capping material and the radicular pulp.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05811403
Brief Title
Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Official Title
The Influence of Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy Using Two Different Calcium Silicate-based Materials on Postoperative Pain and Success Rate in Mature Permanent Molars With Irreversible Pulpitis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the effect of two flushing agents (epigallocatechin gallate (EGCG) and sodium hypochlorite (NaOCl)) during full pulpotomy using two different calcium silicate-based materials (MTA and premixed bioceramic putty) on postoperative pain, success rate and dentin bridge thickness in mature permanent mandibular molars with irreversible pulpitis. Participants will be divided into four groups based on the flushing fluid and the pulp capping material to be used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The investigator will not be blinded because of the nature of the intervention and comparator (the flushing agent and pulp capping material)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGCG as a flushing fluid, MTA as a pulp capping material
Arm Type
Experimental
Arm Title
EGCG as a flushing fluid, Premixed BC putty as a pulp capping material
Arm Type
Experimental
Arm Title
NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material
Arm Type
Experimental
Arm Title
NaOCl as a flushing fluid, MTA as a pulp capping material
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Epigallocatechin gallate (EGCG)
Intervention Description
Epigallocatechin gallate (EGCG) is a white powder that can be obtained from tea leaves. It accounts for 50-60 % of catechin content of tea polyphenols with a wide range of biological activities including antioxidant, antimicrobial, anti-inflammatory, immune regulatory, anti-tumour effects.
Intervention Type
Other
Intervention Name(s)
Sodium hypochlorite (NaOCl)
Intervention Description
Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.
Intervention Type
Other
Intervention Name(s)
Mineral trioxide aggregate (MTA)
Intervention Description
Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.
Intervention Type
Other
Intervention Name(s)
Premixed bioceramic putty
Intervention Description
Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Pain assessments will be made at 24, 48, 72 hours and one week postoperatively using an 11-point NRS. Pain will be categorized into 4 categories as follows: 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
One week
Secondary Outcome Measure Information:
Title
Clinical success
Description
The outcome will be considered successful in case of absence of clinical signs and symptoms indicative of pulpal or periapical pathosis (pain and tenderness to percussion).
Time Frame
One year follow-up
Title
Radiographic success
Description
The outcome will be considered successful in case of complete radiographic healing (PAI score 1 or 2) with absence of any pathosis on recall radiographs such as root resorption.
Time Frame
One year follow-up
Title
Dentin bridge thickness
Description
CBCT scans will be performed at 12 months to measure the thickness of the dentin bridge formed at the interface between the pulp capping material and the radicular pulp.
Time Frame
12 months
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:
Patients of either gender between the age group of 20-40 years.
Systemically healthy patient (ASA I or II).
Mature permanent mandibular molars with:
Extremely deep carious lesion (caries penetrating entire thickness of dentin).
Clinical diagnosis of symptomatic irreversible pulpitis and normal periapical tissue.
Patients who agree to provide written consent and attend for recall appointments.
Exclusion Criteria:
Non-restorable teeth with subgingival caries or badly broken teeth.
Signs of pulpal necrosis; associated sinus tract or swelling.
Negative response to pulp sensibility test.
Poor periodontal support.
Absence of pulp exposure following complete caries removal.
Bleeding from the pulp could not be detected from one or more of the orifices indicating pulp necrosis.
Failure to achieve haemostasis within 10 min following full pulpotomy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anan Medhat
Phone
01098708303
Email
Anan.Medhat@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anan Medhat
Phone
01098708303
Email
Anan.Medhat@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
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