Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05811403
Collaborator
(none)
64
4
17.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Epigallocatechin gallate (EGCG)
  • Other: Sodium hypochlorite (NaOCl)
  • Other: Mineral trioxide aggregate (MTA)
  • Other: Premixed bioceramic putty
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes 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)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: EGCG as a flushing fluid, MTA as a pulp capping material

Other: Epigallocatechin gallate (EGCG)
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.

Other: Mineral trioxide aggregate (MTA)
Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.

Experimental: EGCG as a flushing fluid, Premixed BC putty as a pulp capping material

Other: Epigallocatechin gallate (EGCG)
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.

Other: Premixed bioceramic putty
Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.

Experimental: NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material

Other: Sodium hypochlorite (NaOCl)
Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.

Other: Premixed bioceramic putty
Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.

Active Comparator: NaOCl as a flushing fluid, MTA as a pulp capping material

Other: Sodium hypochlorite (NaOCl)
Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.

Other: Mineral trioxide aggregate (MTA)
Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.

Outcome Measures

Primary Outcome Measures

  1. Postoperative pain [One week]

    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

  1. Clinical success [One year follow-up]

    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).

  2. Radiographic success [One year follow-up]

    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.

  3. Dentin bridge thickness [12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Patients of either gender between the age group of 20-40 years.

  2. Systemically healthy patient (ASA I or II).

  3. 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.

  1. Patients who agree to provide written consent and attend for recall appointments.
Exclusion Criteria:
  1. Non-restorable teeth with subgingival caries or badly broken teeth.

  2. Signs of pulpal necrosis; associated sinus tract or swelling.

  3. Negative response to pulp sensibility test.

  4. Poor periodontal support.

  5. Absence of pulp exposure following complete caries removal.

  6. Bleeding from the pulp could not be detected from one or more of the orifices indicating pulp necrosis.

  7. Failure to achieve haemostasis within 10 min following full pulpotomy.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anan Medhat Mohamed, Assistant lecturer, Ahram Canadian university, Cairo University
ClinicalTrials.gov Identifier:
NCT05811403
Other Study ID Numbers:
  • ENDO 372
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2023