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

Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery. A Double-blind, Randomised, Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Third Molar Extraction Surgery
• Intervention / Treatment: Drug: Amoxilan; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amoxilan; Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day.	Drug: Amoxilan; Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day
Placebo Comparator: Placebo; Patients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day.	Other: Placebo; Patients receive 8 capsules placebo perioperatively and for the next 3 days 6 capsules per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mouth opening restrictions: Change of interincisal distance	Interincisal distance, with maximum mouth opening, is measured with a ruler.	preoperatively as well as on the 1st and 7th postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of swelling	Swelling in the cheek area will be determined using a tape measure and 3D photographs.	preoperatively as well as on the 1st and 7th postoperative day
Change of Visual Analogue Scale (VAS): Bleeding	Patients indicate bleeding symptoms on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome	day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Change of Visual Analogue Scale (VAS): Swelling	Patients indicate swelling on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome	day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Change of Visual Analogue Scale (VAS): Pain	Patients indicate pain on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome	day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: AMOXI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No