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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGCG as a flushing fluid, MTA as a pulp capping material | Experimental |
| |
| EGCG as a flushing fluid, Premixed BC putty as a pulp capping material | Experimental |
| |
| NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material | Experimental |
| |
| NaOCl as a flushing fluid, MTA as a pulp capping material | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin gallate (EGCG) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Pain assessments will be made at 24, 48, 72 hours 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". | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). Clinical success will be evaluated at 3, 6 and 12 months. | One year follow-up |
| Radiographic success |
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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:
Patients who agree to provide written consent and attend for recall appointments.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | Egypt |
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The investigator will not be blinded because of the nature of the intervention and comparator (the flushing agent and pulp capping material)
|
| Sodium hypochlorite (NaOCl) | Other | Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface. |
|
| Mineral trioxide aggregate (MTA) | Other | Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy. |
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| Premixed bioceramic putty | Other | Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material. |
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The outcome will be considered successful in case of normal periapical tissue (PAI score 1 or 2) with absence of any pathosis on recall radiographs such as root resorption. Radiographic success will be evaluated at 3, 6 and 12 months. |
| One year follow-up |
| Dentin bridge formation | CBCT scans will be performed at 12 months follow-up to assess the formation of a dentin bridge at the interface between the pulp capping material and the radicular pulp. | 12 months follow-up |
| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
| D012973 | Sodium Hypochlorite |
| C086631 | mineral trioxide aggregate |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |
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