Comparison of Analgesic Effect of Transdermal and Oral Diclofenac After First Premolar Extraction in Orthodontic Treatment

Efficacy of transdermal patch vs oral diclofenac as an analgesia following maxillary and mandibular first premolar extraction in orthodontic patients: A split mouth study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103661

Enrollment

Registered

2026-02-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Oral Diclofenac tablet 50 mg: Oral Diclofenac tablet 50 mg (VOVERAN 50)given by oral route of administration twice a day postextraction for 1, 2, 3 days Control Intervention1: Diclofena

Eligibility

Inclusion criteria

Inclusion criteria: Bilateral maxillary and mandibular premolar teeth having buccal/lingual plate intact, indicated for orthodontic extraction purposes. American Society of Anaesthesiologists (ASA) type I status of patients.

Exclusion criteria

Exclusion criteria: Failed root canal treated tooth, periapical infections, tooth indicated for extraction for prosthetic reasons & periodontally compromised tooth (Grade II & III Mobile tooth) Unilateral extraction. Patients taking pain altering medication that may interfere with pain response. Medically compromised patients. Tobacco chewers, smokers & alcoholics. Known allergy to a local anaesthetic or requiring repeated injections of local anaesthetics. Patient with known allergy to Non-steroidal anti-inflammatory drugs or other pain killers. Patients requiring surgical extraction. Refused to sign the informed consent. Pregnancy and lactating females and patients on oral contraceptives.

Design outcomes

Primary

Measure	Time frame
Post operative pain Visual Analogue Scale of 0-10 Pain Relief Scale of 0-4 Pain Intensity Scale of 0-4 Patient Compliance Post operative complications assessment at 2 hours 4 hours 8 hours 12 hours and 24 hours on postoperative days 1 2 and 3Timepoint: Post operative pain Visual Analogue Scale of 0-10 Pain Relief Scale of 0-4 Pain Intensity Scale of 0-4 Patient Compliance Post operative complications assessement at 2 hours 4 hours 8 hours 12 hours and 24 hours on postoperative days 1 2 and 3	—

Measure

Time frame

Post operative pain Visual Analogue Scale of 0-10 Pain Relief Scale of 0-4 Pain Intensity Scale of 0-4 Patient Compliance Post operative complications assessment at 2 hours 4 hours 8 hours 12 hours and 24 hours on postoperative days 1 2 and 3Timepoint: Post operative pain Visual Analogue Scale of 0-10 Pain Relief Scale of 0-4 Pain Intensity Scale of 0-4 Patient Compliance Post operative complications assessement at 2 hours 4 hours 8 hours 12 hours and 24 hours on postoperative days 1 2 and 3

—

Secondary

Measure	Time frame
Age,Sex Postoperative pain at 1st 2nd 3rd dayTimepoint: Visual Analogue Scale 1-10 Age,Gender	—

Countries

India

Contacts

Public ContactDr Anshul Sharma

Chhattisgarh Dental College and Research Institute

anshul.sharma63@gmail.com7587139040

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026