Efficacy of Chronoterapy in Oral Surgery (ECOS)

Universidad Complutense de Madrid

Status: Completed

Conditions: Tooth, Impacted; Inflammatory Response; Trismus; Pain

Treatments: Drug: Ibuprofen 400 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05126264

2019-000736-25

Details and patient eligibility

About

Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration. The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (ibuprofen) affects on postoperative pain, swelling and open mouth limitation comparing to the normal dosage.

Full description

A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed ramdomly in one side wit the normal medication dosage while the contralateral side will be prescribed a modified dosage. Moreover, a blood sample will be obtained to analize the inflammatory profile.

Enrollment: 10 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18 and 35 years old
• Bilateral retained lower third molar

Exclusion criteria

• NSAID allergic
• Contraindication for surgical removal of third molar

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Modified dosage

Experimental group

Description:

Ibuprofen pill at morning and afternoon; Placebo at night

Treatment:

Drug: Ibuprofen 400 mg

Drug: Ibuprofen 400 mg

Normal dosage

Active Comparator group

Description:

Ibuprofen three times a day: morning, afternoon and night

Treatment:

Drug: Ibuprofen 400 mg

Drug: Ibuprofen 400 mg