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Completed
NCT07290049
Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy
Conditions: Symptomatic Irreversible Pulpitis, Symptomatic Irreversible Pulpitis (SIP)
Sex: All
Ages: 9 Years – 14 Years
Healthy volunteers: No
Phase: NA
Enrollment: 46
Sponsor: University of Fujairah
Location: Dental Clinic, College of Dentistry, Fujairah University Fujairah Emirate of Fujairah
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07290049). StuddyBuddy aggregates publicly available trial information.