Actively Recruiting
Assessment of Postoperative Pain Incidence in Teeth Affected by Pulpitis, Necrosis, or Previously Treated, Following Obturation With Bioceramic or Resin-based Sealers
Led by University of Siena · Updated on 2025-06-12
270
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Siena
Lead Sponsor
U
Universidad Rey Juan Carlos
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the incidence and intensity of pain after root canal treatments in patients with teeth diagnosed with pulpitis, pulp necrosis, or prior endodontic treatment. This study aims to find out if the type of sealer used during root canal obturation, either bioceramic or resin-based, affects the level of postoperative pain reported by patients. Pain will be measured using the Visual Analogue Scale at three time points: right after treatment, 24 hours later, and 72 hours after treatment. The study involves four treatment groups where root canals will be filled using different combinations of sealers and techniques. One group uses AH Plus resin-based sealer with continuous wave condensation using thermoplasticized gutta-percha. Another uses AH Plus with the single cone technique and cold gutta-percha. The other two groups use NeoSealer Flo bioceramic sealer with either continuous wave condensation or the single cone technique. These methods represent different approaches to obturating the root canal. Participants will be monitored for postoperative pain intensity at specified intervals and assessed for radiographic success using the Periapical Index criteria at least six months after treatment. Clinical success will also be evaluated by checking for absence of symptoms and using CBCT imaging. The total participation timeline includes follow-up assessments six months or more after the initial root canal therapy to observe healing and treatment outcomes.
CONDITIONS
Brief Title
Postoperative Pain Evaluation After Obturation With Different Sealers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and older
- Teeth diagnosed with pulpal necrosis or irreversible pulpitis
- Informed consent provided for data usage
You will not qualify if you...
- Patients with systemic conditions that may impair healing, such as uncontrolled diabetes or immunosuppression
- Asymptomatic presentation
- Teeth with root fractures, resorption, or open apices
- Incomplete clinical or radiographic records
- Poor-quality radiographs or lack of standardization for evaluation purposes only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive root canal obturation using either a resin-based or bioceramic sealer combined with different obturation techniques.
1 treatment visit (in-person)
Duration - At least 6 months
Participants are monitored for postoperative pain and treatment success through clinical and radiographic evaluations.
Follow-up visits for radiographic and clinical assessments over 6 months
Trial Site Locations
Total: 1 location
1
Universidad Rey Juan Carlos , Madrid, Spain 28922
Madrid, Spain, 28922
Actively Recruiting
Research Team
G
Giulia Malvicini, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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