The comparison of novafen and ibuprofen in pain relief caused by orthodontic separators

The comparison of novafen and ibuprofen in pain relief caused by orthodontic separators: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251112067976N1

Enrollment

Registered

2025-12-09

Start date

2025-11-16

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

pain resulting from orthodontic separators.

Interventions

Intervention 1: Intervention group: ibuprofen. Intervention 2: Intervention group: novafen. Intervention 3: Control group: no drug will be given.

Eligibility

Sex/Gender

All

Age

11 Years to 41 Years

Inclusion criteria

Inclusion criteria: Individuals scheduled for orthodontic separators placement. Patients with no contraindications to ibuprofen, novafen The appreciate to participate and provide informed consent Patients without underlying disease Patients who do not take medication

Exclusion criteria

Exclusion criteria: History of allergic reactions or intolerance to ibuprofen, acetaminophen, or caffeine. Contraindications to NSAIDs or acetaminophen (e.g., gastrointestinal bleeding, liver disease) Pregnant or breastfeeding individuals.

Design outcomes

Primary

Measure	Time frame
To compare the effectiveness of novafen and ibuprofen in pain relief caused by orthodontic separators. Timepoint: Participants will complete a three-question pain assessment survey at predetermined intervals (?h,?h after orthodontic separator replacement,bedtime on the day of replacement, next day morning,and the ?nd day, ?rd day, ?th day morning after separator replacement), tracking pain intensity and relief. Method of measurement: questionnaire (VAS).	—

Measure

Time frame

To compare the effectiveness of novafen and ibuprofen in pain relief caused by orthodontic separators. Timepoint: Participants will complete a three-question pain assessment survey at predetermined intervals (?h,?h after orthodontic separator replacement,bedtime on the day of replacement, next day morning,and the ?nd day, ?rd day, ?th day morning after separator replacement), tracking pain intensity and relief. Method of measurement: questionnaire (VAS).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactKawthar Halawi

Tehran University of Medical Sciences

Kawthar.halawikh@gmail.com+98 21 8896 5097

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026