Irreversible Pulpitis Clinical Trial
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
NCT number | NCT05811403 |
Other study ID # | ENDO 372 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | December 1, 2025 |
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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". | One week | |
Secondary | 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). | One year follow-up | |
Secondary | 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. | One year follow-up | |
Secondary | 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. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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