Comparative study of pre-medication with paracetamol, Ibuprofen and placebo on post operative pain following pulpotomy in 6-12 years old children

A split-mouth randomized controlled trial: Comparative study of pre-medication with paracetamol, Ibuprofen and placebo on post operative pain following pulpotomy in 6-12 years old children

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221011056145N1

Enrollment

Registered

2022-10-30

Start date

2022-10-21

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Pulpotomy. Inflammation of the dental pulp, usually due to bacterial infection in dental caries, tooth fracture, or other conditions causing exposure of the pulp to bacterial invasion. Chemical irritants, thermal factors, hyperemic changes, and other factors may als

Interventions

Intervention 1: Intervention group: Ibuprofen. Ibuprofen suspension 100 mg/5 ml (Iran, Tehran, Hakim) is given 45 minutes before treatment based on the weight of each child. Intervention 2: Interventi

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: The children be 6-12 years old Each patient must have at least 3 teeth for Pulpotomy and SSC in lower jaw Parents' consent to perform the treatment

Exclusion criteria

Exclusion criteria: Not reaching hemostasis Not reaching adequate anesthesia Any kind of systemic disease that is in contrast to conservative pulp treatment Any radiographic findings including:internal and external resorption, PDL Widening,furcation and periapical radiolucency,root canal calcification Patients with any history of allergy to analgesics or any drugs used in the study Patients are not reachable through phone call Patients with Gastrointestinal problems, Favism, GERD,Active asthma Patients with prolonged bleeding history Presence of abscess or sinus tract

Design outcomes

Primary

Measure	Time frame
Examining the type of drug on pain after pulpotomy treatment. Timepoint: The treatments are done with an interval of one week, and the child is asked to paint the face that is most similar to his feeling about the treated tooth in the intervals of 24, 48, 72 hours after the treatment. Method of measurement: comparative investigation of pre-treatment with paracetamol, ibuprofen and placebo on pain after pulpotomy treatment in children 6-12 years old" the way of measuring the outcome variable is "Wong-Baker scale".;Examining the age variable on pain after treatment. Timepoint: In the initial treatment session, the age is asked and recorded for each child. Method of measurement: In the initial treatment session, the age is asked and recorded for each child.;Examining the gender variable on pain after treatment. Timepoint: In the initial treatment session, the gender of the child is asked and noted. Method of measurement: In the initial treatment session, the gender of the child is asked and noted.	—

Measure

Time frame

Examining the type of drug on pain after pulpotomy treatment. Timepoint: The treatments are done with an interval of one week, and the child is asked to paint the face that is most similar to his feeling about the treated tooth in the intervals of 24, 48, 72 hours after the treatment. Method of measurement: comparative investigation of pre-treatment with paracetamol, ibuprofen and placebo on pain after pulpotomy treatment in children 6-12 years old" the way of measuring the outcome variable is "Wong-Baker scale".;Examining the age variable on pain after treatment. Timepoint: In the initial treatment session, the age is asked and recorded for each child. Method of measurement: In the initial treatment session, the age is asked and recorded for each child.;Examining the gender variable on pain after treatment. Timepoint: In the initial treatment session, the gender of the child is asked and noted. Method of measurement: In the initial treatment session, the gender of the child is asked and noted.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Hedyeh Daneshvar

Rasht University of Medical Sciences

dr.daneshvar@gums.ac.ir+98 13 3348 6406

Outcome results

None listed

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