Investigating the effect of antibiotic administration on surgical complications of impacted and partially impacted mandibular third molars

Investigating the effect of post-operative antibiotic administration on the complications of impacted and semi-impacted mandibular third molar surgery - a double-blinded randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240903062941N1

Enrollment

260

Registered

2024-09-14

Start date

2024-09-22

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Condition 1: Surgical site infection. Condition 2: Trismus (reduction of maximum mouth opening). Condition 3: Edema (swelling). Infection following a procedure Cramp and spasm Localized edema

Interventions

Intervention 1: Intervention group: In this study, for the intervention group, instructions for taking 15 amoxicillin 500mg capsules (produced by Cosar Pharmaceutical Company) are prescribed, one ever

Eligibility

Sex/Gender

All

Age

16 Years to 35 Years

Inclusion criteria

Inclusion criteria: Healthy individuals (ASA < 2) Age range: 16–35 years Having at least one impacted or semi-impacted wisdom tooth (categories C3, C2, C1, B3, B2 according to Pell & Gregory classification) in the mandible

Exclusion criteria

Exclusion criteria: Individuals with poor oral hygiene (OHI-S < 3) Use of an interfering antibiotic that cannot be discontinued before the study Diagnosis of a systemic disease that interferes with the healing process (based on history-taking and clinical observations) History of pericoronitis in the past 7 days Discharge of pus or serous fluid from the surgical site Use of any immunosuppressive medication History of allergic reaction to penicillin family antibiotics History of allergic reaction to ibuprofen or other NSAIDs History of allergic reaction to chlorhexidine gluconate mouthwash

Design outcomes

Primary

Measure	Time frame
Maximum mouth opening. Timepoint: Measuring the amount of maximum mouth opening at the beginning of the study (before surgery) and 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: For the maximum mouth opening outcome, measuring the distance between the first right incisors in a state where the patient can open his/her mouth as much as possible without pain is used with the help of a measuring gauge.;Surgical site infection. Timepoint: Examining the discharge of pus or serous 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: The discharge of pus or serous from the surgical site is examined in follow-up sessions with the help of clinical examination, and if it is positive then presence of infection is confirmed.;Length of soft tissue from tragus to menton. Timepoint: Measuring the length of soft tissue from the tragus to the menton at the beginning of the study (before the surgery) and 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: For measuring the length of the patient's soft tissue, the mento-tragus length is used as an index. In this process, the two ends of the thread are passively placed on the Menton and Tragus landmarks, then marked. Finally, the thread is transferred onto a ruler, and the distance between the two marked points is recorded in millimeters.	—

Measure

Time frame

Maximum mouth opening. Timepoint: Measuring the amount of maximum mouth opening at the beginning of the study (before surgery) and 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: For the maximum mouth opening outcome, measuring the distance between the first right incisors in a state where the patient can open his/her mouth as much as possible without pain is used with the help of a measuring gauge.;Surgical site infection. Timepoint: Examining the discharge of pus or serous 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: The discharge of pus or serous from the surgical site is examined in follow-up sessions with the help of clinical examination, and if it is positive then presence of infection is confirmed.;Length of soft tissue from tragus to menton. Timepoint: Measuring the length of soft tissue from the tragus to the menton at the beginning of the study (before the surgery) and 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: For measuring the length of the patient's soft tissue, the mento-tragus length is used as an index. In this process, the two ends of the thread are passively placed on the Menton and Tragus landmarks, then marked. Finally, the thread is transferred onto a ruler, and the distance between the two marked points is recorded in millimeters.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Sadeghi

Esfahan University of Medical Sciences

mahdi.2313@gmail.com+98 31 3668 0048

Outcome results

None listed

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