Hydraulic Cements in Partial Pulpotomy (NCT06881615) | Clinical Trial Compass
CompletedNot Applicable
Hydraulic Cements in Partial Pulpotomy
Spain71 participantsStarted 2022-12-01
Plain-language summary
This study is a randomized clinical trial that compares two types of hydraulic cements used in partial pulpotomy procedures for permanent teeth affected by deep decay and pulp inflammation. The purpose of the study is to determine which cement results in better treatment outcomes, such as preserving tooth vitality, reducing pain, and promoting healing. All patients receive a standardized treatment procedure and are then randomly assigned to one of the two cement groups. Key factors such as the time required to achieve hemostasis, the size of the pulp exposure, and other clinical variables are evaluated. Patients are followed up at 15 days and at 1, 3, 6, and 12 months after treatment to assess their clinical and radiographic outcomes. The results of this study will help improve treatment protocols and guide health care providers in selecting the most effective materials for partial pulpotomy.
Who can participate
Age range
18 Years – 88 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 diagnosed with initial, mild, moderate, or severe pulpitis according to the Wolters et al. (2017) classification (Wolters et al., 2017),
* aged between 18 and 88 years
* having a non-contributory medical history.
* only permanent teeth affected by caries and exhibiting a proximity to the pulp-assessed via periapical and bitewing radiographs-with a distance ranging from 0 to 1.5 mm
* required to have fully formed apices,
* a periapical index score of ≤2,
* no tenderness on percussion
* probing pocket depths and mobility within normal limits.
Exclusion Criteria:
* patients diagnosed with pulp necrosis according to the American Association of Endodontists (AAE) guidelines("AAE Consensus Conference Recommended Diagnostic Terminology," 2009);
* patients who declined vital pulp therapy as a treatment option;
* patients with systemic conditions that could affect treatment outcomes.
* teeth were excluded if they exhibited immature roots;
* if no pulp exposure occurred despite complete caries excavation;
* if bleeding after pulpal amputation could not be controlled within the prescribed time (10 minutes)(Taha et al., 2017)
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
Number of Participants with Clinical Success at 15 days
Timeframe: From enrollment to the end of treatment at 2 weeks
2
Number of Participants with Clinical Success at 1,3,6 months
Timeframe: From enrollment to the end of treatment at 1, 3, 6 months
3
Radiographic success
Timeframe: From enrollment to the end of treatment at 1, 3, 6, 12 months
4
Number of Participants with Clinical Success at 12 Months
Timeframe: participants enrolled from end of the treatment to 12 months
5
Mean Pain Score at 15 Days, 1,3,6 and 12 months Using the Numeric Rating Scale (NRS)