Outcomes of Full Pulpotomy Treatment in Teeth With Symptoms of Irreversible Pulpitis (NCT06802536) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Outcomes of Full Pulpotomy Treatment in Teeth With Symptoms of Irreversible Pulpitis
Turkey (Türkiye)60 participantsStarted 2024-04-15
Plain-language summary
The aim of this clinical trial is to learn how successful Biodentine and NeoPutty dental filling materials are in treating dental pulp inflammation in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:
Do Biodentine and NeoPutty dental filling materials treat dental pulpitis in participants? Do they reduce the need for root canal treatment?
After the application of Biodentine and NeoPutty dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment.
The researchers will compare the clinical success of Biodentine and NeoPutty dental filling materials with each other.
Participants will undergo a single-session pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.
Who can participate
Age range
18 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:
* • Patient age must be between 18-50 years
* Must be able to give written informed consent
* Must have systemic status (ASA 1)
* Must have mature permanent molar or premolar (lower upper)
* Must be symptomatic (spontaneous pain - mild to severe), extremely deep (D4) carious teeth
* Must have pulp exposure in non-selective carious cleaning procedure
* Must have vital response in cold test and electric pulp test
* Must have no periodontal disease
* Must have restorable teeth
* Must have teeth without pulp necrosis, sinus tract or swelling/abscess
* Must have bleeding time less than 10 minutes
* Maximum two teeth in a patient must be included in the study (must be in different quadrants and must have at least 2 weeks between treatment periods)
Exclusion Criteria:
* Teeth with incomplete root development
* Teeth without symptoms of irreversible pulpitis
* Severely affected teeth that do not respond to pulp sensitivity tests
* Teeth without signs of bleeding after exposure with the pulp chamber
* Teeth with pulp chamber open to the oral environment
* Teeth with periodontal pockets greater than 4 mm deep
* Teeth with suspected cracks or crown fractures that may be responsible for pulp pathology
* Teeth with uncontrolled bleeding
* Medically risky patients will be excluded from the study.
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
"Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency.
Timeframe: From enrollment to the end of treatment at 1 year"