About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Calcium Silicate Cement
DeviceA premixed, ready-to-use hydraulic tricalcium silicate cement (commercial name: EndoCem MTA Pre-mixed Putty) used as a direct pulp-capping agent. It is applied over the vital radicular pulp tissue following a pulpotomy procedure to seal the pulp chamber and promote healing and reparative dentin formation. The material is used according to the manufacturer's instructions for vital pulp therapy.
Er,Cr:YSGG Laser
DeviceAn Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser system used in a non-ablative, low-level power setting for biomodulation. Following hemostasis in the pulpotomy procedure, the laser tip delivers photonic energy to the exposed pulp stumps in a defocused, non-contact mode. The intended biological effects are biostimulation of pulpal cells, enhanced healing, and anti-inflammatory action, which may reduce postoperative pain. Specific parameters (e.g., power, frequency, air/water coolant ratio) are set for therapeutic bio-stimulation rather than surgical cutting.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Pain Intensity as assessed by Visual Analogue Scale (VAS)
Postoperative pain level will be self-reported by participants using a 100-mm Visual Analogue Scale (VAS). The scale is a horizontal line anchored by two verbal descriptors: "No pain" (0 mm) on the left and "Worst pain imaginable" (100 mm) on the right. Participants mark the line at the point that best represents their pain intensity. A higher score indicates greater pain. The outcome for analysis is the mean VAS score recorded at each specified postoperative time point.
Secondary outcomes
Clinical Success Rate
The absence of clinical signs and symptoms of failure, including spontaneous pain, pain on palpation, pain on percussion, soft tissue swelling, sinus tract, or pathological tooth mobility. The outcome is reported as the number of participants with a clinically successful outcome.
Radiographic Success Rate
The absence of radiographic signs of failure, assessed via periapical radiographs. This includes the absence of new or enlarged periapical radiolucency, external or internal root resorption, or periodontal ligament space widening. The outcome is reported as the number of participants with a radiographically successful outcome.
Other outcomes
Incidence of Analgesic Medication Use
The number of participants who take rescue analgesic medication (e.g., Ibuprofen) for pain relief following the procedure. This is used as an indirect, patient-driven measure of significant postoperative pain.
Sponsors and contacts
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