Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without La… (NCT07290049) | Clinical Trial Compass
RecruitingNot Applicable
Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy
United Arab Emirates46 participantsStarted 2025-04-24
Plain-language summary
This study is for children and young adults who have a severe toothache in a permanent back molar, caused by an inflamed nerve (a condition called irreversible pulpitis). Usually, the treatment for this is a root canal, which removes the entire nerve. However, a different treatment called "vital pulp therapy" or "pulpotomy" may be an option. This simpler procedure removes only the infected part of the nerve, leaving the healthy part alive, and then seals the tooth with a special material.
The goal of our research is to see if we can make this pulpotomy procedure even more comfortable for patients afterward. We are testing two approaches:
Using a modern dental filling material called EndoCem to seal the tooth.
Using the same EndoCem material, but first applying a gentle laser to the healthy nerve tissue. This laser treatment, known as "biomodulation," is thought to help calm the tissue and improve healing.
Patients who join the study will be randomly assigned to one of these two treatment groups. The main thing we will measure is the level of pain after the procedure, which patients will record on a simple pain scale. We want to find out if using the laser in addition to the filling material leads to less pain and a better experience after the treatment.
This study will help dentists understand if combining this new sealing material with laser therapy can be a more effective and comfortable way to save a tooth with a severe toothache.
Who can participate
Age range
9 Years – 14 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 between 9 and 14 years of age. Must have a two-rooted mandibular molar tooth (lower back tooth). The tooth must be diagnosed with symptomatic irreversible pulpitis (a painful, inflamed nerve).
The tooth must be considered restorable (can be fixed with a filling or crown). Patient and/or guardian must be able to understand and sign the informed consent form.
The tooth must be periodontally healthy, with no mobility, and not painful to tapping or pressing.
Exclusion Criteria:
Teeth with immature root tips. Teeth that are not restorable (severely damaged or decayed). Bleeding from the tooth's nerve that cannot be controlled within 10 minutes during the procedure.
Patients with significant medical conditions that could complicate dental treatment.
Teeth with a dead (necrotic) nerve. Inability or unwillingness to provide informed consent. Individuals from vulnerable groups (as defined by the ethics committee).
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
Postoperative Pain Intensity as assessed by Visual Analogue Scale (VAS)
Timeframe: At 6, 12, 24, and 48 hours after the completion of the pulpotomy procedure.