Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without La… (NCT07290049) | Clinical Trial Compass
CompletedNot 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 evaluates treatment options for children and young adults with severe toothache in a permanent molar caused by symptomatic irreversible pulpitis. Conventional treatment involves non-surgical root canal treatment, which removes the entire dental pulp. An alternative approach, vital pulp therapy (full pulpotomy), removes only the inflamed coronal pulp while preserving the healthy radicular pulp, followed by placement of a bioactive calcium silicate cement.
The study compares two pulpotomy protocols. One group will receive EndoCem as the pulpal dressing material, while the other group will receive Er,Cr:YSGG laser biomodulation of the remaining pulp tissue before placement of EndoCem. Laser biomodulation is intended to reduce inflammation and promote tissue healing.
Participants will be randomly assigned to one of the two treatment groups. The primary outcome is postoperative pain, which will be assessed using a Visual Analogue Scale (VAS) at predetermined time points after treatment. The study aims to determine whether adjunctive laser biomodulation reduces postoperative pain compared with EndoCem alone and improves patient comfort following full pulpotomy.
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
* Presence of a two-rooted permanent mandibular molar
* Clinical diagnosis of symptomatic irreversible pulpitis in the study tooth
* Study tooth considered restorable with a definitive restoration
* Study tooth is periodontally healthy, with no mobility and no tenderness to percussion or palpation
* Participant and/or parent/legal guardian is able and willing to provide written informed consent
Exclusion Criteria:
* Teeth with immature root apices
* Teeth that are non-restorable because of extensive caries or structural damage
* Inability to achieve hemostasis within 10 minutes after coronal pulp removal
* Participants with significant systemic medical conditions that may affect dental treatment or healing
* Teeth diagnosed with pulpal necrosis
* Inability or unwillingness of the participant and/or parent/legal guardian to provide informed consent
* Individuals belonging to vulnerable populations, as defined by the institutional 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.