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Completed

NCT Number: NCT07817940

Antibiotic Therapy in Impacted Mandibular Third Molar Surgery

This study compared three antibiotic approaches in healthy young adults undergoing surgical removal of impacted lower wisdom teeth: a single dose of antibiotics before surgery, antibiotic treatment after surgery, and no antibiotics. Participants had similar impacted lower wisdom teeth on both sides and underwent surgery in two separate sessions. The study evaluated postoperative pain, facial swelling, mouth opening, and changes in blood markers related to inflammation, including C-reactive protein, erythrocyte sedimentation rate, procalcitonin, and white blood cell counts. The aim was to determine whether antibiotic use before or after surgery affected postoperative recovery and systemic inflammatory responses compared with no antibiotic use.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bolu Abant Izzet Baysal University, Faculty of Dentistry

Bolu, 14030, Turkey (Türkiye)

About this study

This prospective randomized study included 30 systemically healthy young adults with bilaterally symmetrical, asymptomatic impacted mandibular third molars classified as Pell and Gregory Class II, Position B. Each participant underwent two surgical procedures, performed four weeks apart by the same surgeon. Three antibiotic strategies were evaluated: a single preoperative antibiotic dose, postoperative antibiotic therapy, and no antibiotic treatment. Because each participant received two of the three interventions, participants were assigned to one of three treatment sequences. Clinical outcomes, including postoperative pain, facial swelling, and maximum mouth opening, were assessed during follow-up. Blood samples were collected before surgery and on postoperative days 1, 3, and 7 to evaluate systemic inflammatory biomarkers, including C-reactive protein, erythrocyte sedimentation rate, procalcitonin, and white blood cell parameters.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older Systemically healthy status Presence of bilateral, symmetrical, asymptomatic impacted mandibular third molars classified as Pell and Gregory Class II, Position B No antibiotic use within the 4 weeks preceding surgery Ability and willingness to provide written informed consent

Exclusion criteria

  • Uncontrolled systemic disease Pregnancy or lactation Active pericoronal infection History of allergy to amoxicillin, clavulanic acid, or articaine hydrochloride Presence of local pathology at the surgical site Previous radiotherapy to the head and neck region Syndromic conditions Any postoperative complication following the first surgery that prevented completion of the second surgical procedure according to the study protocol

Treatment and study plan

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

Drug

Amoxicillin-clavulanate 875/125 mg was administered twice daily for 7 days after surgery.

Primary outcomes

  1. Change in Serum C-Reactive Protein (CRP) Level

    Time frame: Baseline (preoperative) and postoperative days 1, 3, and 7

    Serum C-reactive protein (CRP) levels were measured to assess the systemic inflammatory response following impacted mandibular third molar surgery and to compare the effects of preoperative antibiotic prophylaxis, postoperative antibiotic therapy, and no antibiotic therapy. CRP levels were measured using an Architect c16000 automated analyzer (Abbott Laboratories, Abbott Park, IL, USA).

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

Effects of Preoperative and Postoperative Antibiotic Therapy on Clinical Outcomes and Systemic Inflammatory Biomarkers Following Impacted Mandibular Third Molar Surgery: A Prospective Randomized Double-Blind Split-Mouth Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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