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Analgesic efficacy of mucosal diclofenac patch on post-endodontic pain

Analgesic efficacy of mucosal diclofenac patch on post-endodontic pain - a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190716044230N2
Enrollment
54
Registered
2020-04-23
Start date
2020-05-21
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Irreversible pulpitis (dental). Other diseases of pulp and periapical tissues

Interventions

Intervention 1: Intervention group: material in use: Diclofenac, delivery system: mucosal patch (produced by Shahid Beheshti pharmacy school), drug concentration in each patch: 1% (may alter during dr

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients who are between 18 and 65 years old. Patients whose physical status is classified as Class I American Society of Anesthesiologists (ASA) Maxillary and mandibular first or second molar with irreversible pulpitis diagnosis. Subjects who have no swelling or fistula. Patients with positive response to electrical pulp testing and prolonged mild to moderate pain following cold pulp test confirming an irreversible pulpitis diagnosis for each tooth.

Exclusion criteria

Exclusion criteria: Subjects with any systemic disorder, gastrointestinal disease or allergy that interferes with diclofenac. Patients who are allergic to local anesthesia drugs or sulfite. Subjects with a teeth that can not be restorated or teeth with severe periodontal disease which are not suitable for endodontic treatment. Patients who have taken any analgesic medication 12 hours prior to the appointment. Patients who are not in a position to give informed consent. Patients who are unable to read or write. Patients with spontaneous pain requiring emergency treatment. Women pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Pain intensity after root canal treatment. Timepoint: Pain measurement immediately after root canal treatment and 2, 4, 8, 24, 48, 72 hours after the treatment. Method of measurement: Numeric Rating Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeede Zadsirjan

Shahid Beheshti University of Medical Sciences

S_sirjani@yahoo.com+98 21 2241 3896

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026