Symptomatic Irreversible Pulpitis
Conditions
Keywords
Pulpotomy, Mineral Trioxide Aggregate (MTA), Biodentine, Vital pulp therapy, Postoperative pain, Overall success
Brief summary
The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.
Detailed description
* Patients will be clinically and radiographically examined and their eligibility will be assessed. * Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA). * After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA * The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken. * The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times. * The patients will be recalled after 6 and 12 months post-operatively.
Interventions
PROCEDUREMTA Pulpotomy.
Pulpotomy using MTA.
PROCEDUREBiodentine Pulpotomy
Pulpotomy using Biodentine
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The study will be participant-blind where the participant will not know the intervention done.
Intervention model description
Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients aging between 18-40 years old * Patients with symptomatic irreversible pulpitis. * Radiographically: Absence or slight widening in periodontal ligament space. * Systemically- healthy patients (ASA I or II). * Patients who agree to attend for recall appointments and provide written consent.
Exclusion criteria
* Severe marginal periodontitis. * Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula. * Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain after 6 hours postoperatively | 6 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents no pain 1- 3 readings represent mild pain 4- 6 readings represent moderate pain 7- 10 readings represent severe pain |
| Postoperative pain after 12 hours postoperatively | 12 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents no pain 1- 3 readings represent mild pain 4- 6 readings represent moderate pain 7- 10 readings represent severe pain |
| Postoperative pain after 24 hours postoperatively | 24 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 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 |
|---|---|---|
| Overall (clinical and radiographic) success after 6 months postoperatively. | 6 months postoperatively | Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure. |
| Overall (clinical and radiographic) success after 12 months postoperatively. | 12 months postoperatively | Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure. |
Contacts
Primary ContactYoussef A. Kamal Elalfy, B.D.S
Backup ContactSuzan AW Amin, Ph.D.
Outcome results
None listed