Antibiotic Therapy in Impacted Mandibular Third Molar Surgery

NCT07817940 | Completed Phase 4

• 1 other identifier: AIBU-DH-OFB-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impacted Lower Third Molar

Keywords

Procalcitonin; antibiotic prophylaxis; C-reactive protein

Outcome Measures

Primary Outcomes (1)

• Change in Serum C-Reactive Protein (CRP) Level

  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).

  Baseline (preoperative) and postoperative days 1, 3, and 7

Study Arms (3)

Preoperative Antibiotic

EXPERIMENTAL

Participants received a single 2 g dose of amoxicillin-clavulanate before impacted mandibular third molar surgery.

Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

Postoperative Antibiotic

ACTIVE COMPARATOR

Participants received amoxicillin-clavulanate 875/125 mg twice daily for 7 days after impacted mandibular third molar surgery

Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

No Antibiotic

NO INTERVENTION

Participants underwent impacted mandibular third molar surgery without preoperative or postoperative antibiotic treatment.

Interventions

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet DRUG

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

Postoperative Antibiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University, Faculty of Dentistry

Bolu, Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants underwent two surgical sessions, four weeks apart, and received two of the three antibiotic strategies according to a randomized balanced incomplete-block crossover design with a split-mouth component.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 14, 2026
• Study Start: November 14, 2023
• Primary Completion: December 26, 2024
• Study Completion: December 26, 2024
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)