Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery.

NCT ID: NCT05142449

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2022-09-01

Brief Summary

59 medically healthy patients, who are scheduled for third molar extraction surgery and give informed consent for the trial, are operated using a split-mouth technique.

One group of patients will be assigned to the test group (Amoxilan) for the first surgery and to the control group (placebo) for the second surgery, and vice versa, according to randomisation.

Patients receive 8 capsules Amoxilan or placebo (according to randomisation) perioperatively, and 6 capsules Amoxilan/placebo per day for 3 days postoperativeley.

Conditions

Third Molar Extraction Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Amoxilan

Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day.

Group Type: EXPERIMENTAL

Amoxilan

Intervention Type: DRUG

Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day

Placebo

Patients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients receive 8 capsules placebo perioperatively and for the next 3 days 6 capsules per day

Interventions

Amoxilan

Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day

Intervention Type: DRUG

Placebo

Patients receive 8 capsules placebo perioperatively and for the next 3 days 6 capsules per day

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Symptom-free, bilaterally located third molars
• Medically healthy patient ≥ 16 years
• No allergies/intolerances against the investigational product/placebo
• Informed consent

Exclusion Criteria

• General contraindications to wisdom tooth extraction surgery
• (Former) heavy smoking
• Use of antibiotics within the last three months or patients requiring antibiotic treatment prior to surgery
• (Planned) Pregnancy/lactating

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie

Graz, , Austria

Countries

Austria

Other Identifiers

AMOXI

Identifier Type: -

Identifier Source: org_study_id