Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp Treatments (NCT05902936) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp Treatments
Egypt30 participantsStarted 2023-03-01
Plain-language summary
With consideration of the previous studies regarding the properties of i-PRF, it will be used in combination with another bioactive material: (Nano-BAG) versus using of i-PRF only as a pulpotomy material with using a premixed bioceramic putty as a coronal sealing material in both cases, to evaluate if there is a difference in the success rate of pulpotomy in case of using Nano-BAG in combination with i-PRF
So, in this study the investigators will use Nano-BAG in combination with i-PRF as a material for pulpotomy in cases of mature permanent mandibular molars and compare its outcomes with using i-PRF only and in both cases pulpotomy material will be covered with a layer of premixed bioceramic putty for coronal sealing.
Who can participate
Age range
10 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Patients suffering from symptomatic irreversible pulpitis.
* Tooth should give positive response to cold test
* Heamostatis should be achieved after complete pulpotomy
* Diagnosis is irreversible pulpitis with/without apical periodontitis
* The tooth is restorable and free from advanced periodontal disease
* Tooth is free from cracks or splits
* Patients should be free from any systemic disease that may affect normal healing and predictable outcomes.
* Patients who will agree to the consent and will commit to follow-up period.
* Patients with mature root (closed apices)
* Teeth with no periapical lesion, resorption or widening.
* Soft tissues around the tooth are normal with no swelling or sinus tract
* Mandibular posterior teeth only will be involved.
Exclusion Criteria:
* • Patients with immature root apices.
* Patients with any systemic disease that may affect normal healing.
* Patients with periapical lesions or infections.
* If heamostasis couldn't be achieved within 5-10 minutes
* Pregnant females.
* Patients who could/would not participate in a 6 months follow-up.
* Patients with fistula or swelling
* Patients with necrotic pulp.
* Patients with old age.
* Badly destructed teeth
* Teeth that are non-restorable
* Teeth that require post and core build up
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain measurement (change is being assessed)
Timeframe: After 24 hours and up to 7 days for postoperative pain evaluation using Visual Analogue Scale.