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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.
Full description
This study is a prospective, triple-blind, randomized controlled trial with two parallel arms and a 1:1 allocation ratio. It investigates the efficacy of adjunctive Er,Cr:YSGG laser biomodulation in managing postoperative pain following full pulpotomy procedures in permanent molars diagnosed with symptomatic irreversible pulpitis.
The standard of care for teeth with this diagnosis has traditionally been non-surgical root canal treatment (NSRCT), which involves the complete removal of the dental pulp. However, with the advent of advanced bioceramic materials like calcium silicate cements, Vital Pulp Therapy (VPT), specifically pulpotomy, has emerged as a scientifically valid treatment alternative for mature permanent teeth. Pulpotomy aims to preserve the vitality and health of the radicular pulp tissue, potentially offering biological advantages such as maintaining the tooth's proprioceptive and defensive mechanisms, while also being a less complex and more time-efficient procedure.
The primary material under investigation is EndoCem, a premixed, ready-to-use calcium silicate cement. These materials are favored in VPT due to their excellent bioactivity, biocompatibility, and ability to form a hermetic seal over the vital pulp tissue. The experimental intervention involves the application of Er,Cr:YSGG laser energy to the exposed radicular pulp stumps following hemostasis, prior to the placement of the EndoCem cement. The laser parameters will be set to a non-ablative, bio-stimulatory mode. The proposed mechanism of action includes biostimulation of pulpal fibroblasts and stem cells, enhanced local microcirculation, and anti-inflammatory effects, which collectively may lead to a more favorable and less painful postoperative healing response.
Participants will be recruited from the patient pool presenting at the outpatient clinic. After screening against the eligibility criteria, eligible participants (or their guardians) who provide informed consent will be randomized into one of two groups:
Group 1 (Control): Will receive a full pulpotomy procedure followed by the application of EndoCem cement as the pulpal medicament and final restoration.
Group 2 (Intervention): Will receive an identical full pulpotomy procedure, followed by Er,Cr:YSGG laser biomodulation of the pulp stumps, and then the application of EndoCem cement and final restoration.
The randomization sequence will be computer-generated, and allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. To maintain blinding, the operating clinician will not be involved in postoperative assessments. The participant, the outcome assessor (who collects the pain scores), and the statistician analyzing the data will all be blinded to the group assignments.
The primary outcome is postoperative pain, which will be quantitatively measured using a Visual Analogue Scale (VAS). Participants will record their pain levels at predetermined time points following the procedure (e.g., 6, 12, 24, and 48 hours). The data will be analyzed to compare the mean pain scores and the incidence of moderate-to-severe pain between the two groups over time.
This study aims to provide high-level evidence on the potential synergistic effect of laser biomodulation when combined with modern bioceramics in VPT. The results could contribute to optimizing clinical protocols for managing irreversible pulpitis, shifting the paradigm towards more conservative, pulp-preserving treatments that enhance postoperative patient comfort.
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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).
Primary purpose
Allocation
Interventional model
Masking
46 participants in 2 patient groups
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Central trial contact
Nabeel Ayappali Kalluvalappil, MDS
Data sourced from clinicaltrials.gov
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