Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth (NCT06802549) | Clinical Trial Compass
CompletedPhase 4
Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth
Turkey (Türkiye)61 participantsStarted 2024-03-20
Plain-language summary
The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:
Do Biodentine and Theracal PT dental filling materials treat exposed tooth decay in participants? Do they reduce the need for root canal treatment? After the application of Biodentine and Theracal PT 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 Theracal PT dental filling materials with each other.
Participants will undergo a single-session partial 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 should be between 18-50 years
* Should be able to give written informed consent
* Should have systemic status (ASA 1)
* Should have permanent molar or premolar (lower and upper) root development
* Should be asymptomatic, deep (D3) or extremely deep (D4) caries
* Should give vital response in cold test and electric pulp test
* Should have teeth where the pulp is exposed with caries
* Should not have pain during palpation and percussion
* Should not have periodontal disease
* Should have restorable teeth
* Should have teeth without pulp necrosis, sinus tract or swelling/abscess
* Should have bleeding time less than 10 minutes
* Should be able to include a maximum of two teeth in a patient in the study (should be in different quadrants and there should be at least 2 weeks between treatment periods)
Exclusion Criteria:
* Teeth with incomplete root development
* Severely affected teeth that do not respond to pulp sensitivity tests
* Teeth with signs and symptoms of irreversible pulpitis
* Teeth without signs of bleeding after communicating 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 at-risk 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