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Adjunctive Irrigation Strategies for Postoperative Pain After Full Pulpotomy

Adjunctive Irrigation Strategies for Pain Control After Full Pulpotomy in Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07233577
Enrollment
72
Registered
2025-11-18
Start date
2024-12-18
Completion date
2025-06-16
Last updated
2026-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

Brief summary

The goal of this clinical trial is to evaluate the effects of cryotherapy and dexamethasone on the intensity of postoperative pain in full pulpotomy procedures in permanent molars with symptomatic irreversible pulpitis. The main questions it aims to answer are: * Does controlled irrigation with cold saline during full pulpotomy reduce the severity of postoperative pain? * Does controlled irrigation with dexamethasone during full pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone groups, the pulp chamber was irrigated with 2°C saline solution during the final irrigation step. In the dexamethasone group, unlike the control and cryotherapy groups, the pulp chamber was irrigated with 2 mL dexamethasone solution during the final irrigation step.

Interventions

OTHERCryotherapy

In the cryotherapy group, the pulp chamber was irrigated with 5 mL of sterile saline solution pre-cooled to 2.5°C during full pulpotomy.

In the dexamethasone group, the pulp chamber was irrigated with 2 mL of dexamethasone sodium phosphate solution (4 mg/mL) during full pulpotomy.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Vital permanent molars exhibiting positive responses to both the cold test and the electric pulp test, with a prolonged cold response (\>30 seconds) consistent with symptomatic irreversible pulpitis. * Presence of deep carious lesions in the included teeth (indicated for vital pulp therapy). * No radiographic evidence of periapical pathology (i.e., no periapical radiolucency, root resorption, or pathological widening of the periodontal ligament space). * Patients who had not taken analgesics or antibiotics during the 24 hours preceding the procedure.

Exclusion criteria

* Devital permanent molars that responded negatively to cold tests and electric pulp tests * Permanent molars with poor periodontal status (pocket depth \> 4 mm), * Teeth that exhibited periapical radiolucency, pathological mobility, or were deemed non-restorable * Systemic diseases, pregnancy or lactation, known allergies to dexamethasone or NSAIDs, recent use of analgesics (within 24 hours), and any contraindications for pulpotomy or local anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scaleup to 72 hoursThe visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORKoray Yılmaz, DDS, MSc, Professor

Cukurova University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 20, 2026