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

Phase 4

Completed

• Conditions: Third Molar Extraction Surgery
• Interventions: Drug: Amoxilan; Other: Placebo

• Registration Number: NCT05142449
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-25
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-02
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie; 🇦🇹 Graz, Austria