Irreversible Pulpitis
Conditions
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.
Interventions
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.
OTHERSodium hypochlorite (NaOCl)
Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.
Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.
Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 72 hours | 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". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). Clinical success will be evaluated at 3, 6 and 12 months. |
| Radiographic success | One year follow-up | 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. |
| Dentin bridge formation | 12 months follow-up | 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. |
Countries
Egypt
Outcome results
None listed