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Efficacy of anti-inflammatory association in postoperative discomfort control: randomized controlled trial

Efficacy of Ibuprofen with Arginine co-administered with dexamethasone in the control of pain, trismus and postoperative edema in third molar surgeries: a randomized triple blind trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8cdy6v
Enrollment
Unknown
Registered
2020-01-09
Start date
2017-12-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Prevention of postoperative morbidity,represented by pain, trismus and edema in healthy human volunteers, after third molar removal surgery. Molar, third. Pain.Edema.Trismus.

Interventions

Other
Q65.070
The study design was a split-mouth clinical trial,in which all 30 participants received orally an association of ibuprofen with arginine (600mg, 1 dispersible granulate)dexamethasone (8mg, 1 tablet)on
Drug
Procedure/surgery

Sponsors

UFPE- Universidade Federal de Pernambuco
Lead Sponsor
UFPE- Universidade Federal de Pernambuco
Collaborator

Eligibility

Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients between the ages of 18 and 45 years, healthy, who did not present systemic alterations nor made continuous use of medications, that did not report reactions or processes allergic to the drugs used in the research. The third mandibular third molars should be present at the same angulation, mesioangular, distoangular, vertical or horizontal, (Figure 1), with similar root formation, in addition to the same degree of inclusion in relation to the classification of Pell and Gregory (Figures 2) . The teeth should be included or semi-included, ie completely erupted teeth were not included. To be included in the research the patient should be free of pericoronitis in the last 30 days before surgery, and the region without phlogistic signs.

Exclusion criteria

Exclusion criteria: Do not agree to participate in the research after reading the free and informed consent form; Do not fit the planning of surgical and anesthetic techniques; Do not return to the second surgery (surgery on the opposite side); Use other medications in the postoperative period.

Design outcomes

Primary

MeasureTime frame
Postoperative morbidity, measured by the evaluation of trismus, pain and edema.The edema was evaluated using a tape measure, and three imaginary linear measurements were performed on the patient. The distance from the corner of the eye to the angle of the mandible, tragus to the corner of the mouth, and tragus to the soft pogonium were measured. The trismus was measured through the digital caliper (Mitutoyo®) between the upper and lower left central incisors. Pain assessed by visual analogue scale (VAS). ;Patient satisfaction with the therapy used. Overall assessment was the method in which patients rated their treatment-related satisfaction using the 5-point Likert scale (0, bad, 1, reasonable, 2, good, 3, very good, and 4, excellent).

Secondary

MeasureTime frame
Total amount of rescue analgesics ingested.Total rescue analgesics ingested. Patients were asked to note the amount of analgesics ingested within 72 hours after the intervention.;Pain score, measured through the Visual Analogue Scale (EVA), used in the form of a ruler, presented to the individual with the numbers from zero (without pain) to ten (unbearable pain). The patient was asked to mark the intensity of his pain, from the first 30 minutes after surgery, and consequently followed the intervals of 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours.

Countries

Brazil

Contacts

Public ContactHelder Rebelo

UFPE- Universidade Federal de Pernambuco

rebelo_al@hotmail.com+55812126-8817

Outcome results

None listed

Source: REBEC (via WHO ICTRP)