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OpenTrials
Completed

NCT Number: NCT05142449

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

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.

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Key information

Conditions

Third Molar Extraction Surgery

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxilan

Drug

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

Placebo

Other

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

Primary outcomes

  1. Mouth opening restrictions: Change of interincisal distance

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

    Interincisal distance, with maximum mouth opening, is measured with a ruler.

Secondary outcomes

  1. Change of swelling

    Time frame: 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.

  2. Change of Visual Analogue Scale (VAS): Bleeding

    Time frame: 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

  3. Change of Visual Analogue Scale (VAS): Swelling

    Time frame: 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

  4. Change of Visual Analogue Scale (VAS): Pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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