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

Cairo University (CU)

Status: Active, not recruiting

Conditions: Irreversible Pulpitis

Treatments: Other: Sodium hypochlorite (NaOCl); Other: Mineral trioxide aggregate (MTA); Other: Premixed bioceramic putty; Other: Epigallocatechin gallate (EGCG)

Study type: Interventional

Funder types: Other

Identifiers

NCT05811403

ENDO 372

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 4 patient groups

EGCG as a flushing fluid, MTA as a pulp capping material

Experimental group

Treatment:

Other: Epigallocatechin gallate (EGCG)

Other: Mineral trioxide aggregate (MTA)

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

Experimental group

Treatment:

Other: Epigallocatechin gallate (EGCG)

Other: Premixed bioceramic putty

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

Experimental group

Treatment:

Other: Premixed bioceramic putty

Other: Sodium hypochlorite (NaOCl)

NaOCl as a flushing fluid, MTA as a pulp capping material

Active Comparator group

Treatment:

Other: Mineral trioxide aggregate (MTA)

Other: Sodium hypochlorite (NaOCl)