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

NCT05142449 | Completed Phase 4

• 1 other identifier: AMOXI
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of swelling

  preoperatively as well as on the 1st and 7th postoperative day

• Change of Visual Analogue Scale (VAS): Bleeding

  day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery

• Change of Visual Analogue Scale (VAS): Swelling

  day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery

• Change of Visual Analogue Scale (VAS): Pain

  day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery

Study Arms (2)

Amoxilan

EXPERIMENTAL

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

Drug: Amoxilan

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Amoxilan DRUG

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

Amoxilan

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

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

Graz, 8010, Austria

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 2, 2021
• Study Start: March 25, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

AU (1)