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prevention of orthodontic pain

The comparison of the effect of 5% naproxen gel and the placebo gel on reduction of fixed orthodontic pain after elastic separator placement; a randomized clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016010716466N4
Enrollment
30
Registered
2016-03-07
Start date
2016-01-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

The effect of 5% naproxen gel on orthodontic pain reduction.

Interventions

Intervention 1: Naproxen gel, 5%, every 8 hours up to 3 days. Intervention 2: Placebo gel, every 8 hours, up to 3 days.
Prevention
Placebo
Naproxen gel, 5%, every 8 hours up to 3 days
Placebo gel, every 8 hours, up to 3 days

Sponsors

Shahid Beheshti University of Medical Science, School of Dentistry, Orthodontic department
Lead Sponsor
Shahid Beheshti University of Medical Science, School of Dentistry
Collaborator

Eligibility

Sex/Gender
All
Age
14 Years to 20 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Men and female with 14-20 year old of ages; patients have no pain in teeth and gingiva at the beginning of study.; presence of tight contact between first molar with adjacent teeth and clinician needs to place bilateral elastic separators for molar banding and there is no space between the teeth in the jaw.; Patients are without posterior open bite and the first molars should have antagonist teeth in the opposite jaw.; patients present pain after separator placement. Exclusion criteria: Patients who do not use naproxen gel and placebo gel will be omitted from the study.; patients who do not complete all parts of the questionnaire forms will be omitted from the study.; patients who use other analgesic drugs during the study will be omitted.; removal of any of separators

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain after orthodontic separator placement. Timepoint: 2hours after first use, 6 hours after first use, 10A.M and 6 P.M on days 2,3 and 7 after separator placement. Method of measurement: Visual Analogue Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzade Kianipour

Shahid Beheshti University of Medical Science, School of Dentistry

azadehkianipour@ymail.com+98 83 3423 0357

Outcome results

None listed

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