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Comparing the Incidence of Gastrointestinal Side Effects of Ibuprofen and Paracetamol Combination With and Without a Proton Pump Inhibitor in Patients Undergoing Dental Extractions: A Randomized Controlled Trial

Assessment of Incidence of gastrointestinal side-effects of ibuprofen and paracetamol in patients undergoing intra-alveolar dental extractions:A cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089077
Enrollment
160
Registered
2025-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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: Tab.Ibuprofen (400mg) + Tab.Paracetamol (325mg) mg BD for 3 days.: Participants will be followed up on Post-Operative Day 3 and Post-Operative Day 7 and assessed for any incidence of G

Sponsors

MGM Dental College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants in the age group of 18 – 60 years. 2.Participants undergoing routine intra-alveolar extraction. 3.Patients prescribed only a fixed dose combination of Tab.Ibuprofen (400 mg ) + Tab.Paracetamol (325 mg ) will be included. 4.Participants willing to participate in the study. 5.Participants willing to undergo follow up

Exclusion criteria

Exclusion criteria: 1. Age 60 years and above 2. Dyspepsia history 3.Current high dose of Non-Steroidal Anti-Inflammatory Drug (NSAID). 4.Multiple NSAID therapy 5.Peptic ulcer history 6.Concomitant use of corticosteroids 7.Concomitant use of oral anticoagulants 8. Helicobacter pylori infection 9.Cigarette smoking 10.Alcohol use 11. Chronic debilitating disorders, especially cardiovascular disease 12.Enteric coated tablets 13.Patients prescribed antibiotics. 14.Patients exhibiting dental infection.

Design outcomes

Primary

MeasureTime frame
Nausea,Acid Reflux,Epigastric distressTimepoint: Post-operative day 3 and Post-operative day 7

Secondary

MeasureTime frame
Variations in incidence of nausea,acid reflux and epigastric distress with age and genderTimepoint: Post-operative day 3 and Post-operative day 7

Countries

India

Contacts

Public ContactDr.Sunil Sidana

MGM Dental College and Hospital

drsunilsidana@gmail.com9820798821

Outcome results

None listed

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