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

Primary Purpose

Third Molar Extraction Surgery

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Amoxilan
Placebo
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Third Molar Extraction Surgery

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amoxilan

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mouth opening restrictions: Change of interincisal distance
Interincisal distance, with maximum mouth opening, is measured with a ruler.

Secondary Outcome Measures

Change of swelling
Swelling in the cheek area will be determined using a tape measure and 3D photographs.
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
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
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

Full Information

First Posted
November 24, 2021
Last Updated
October 7, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05142449
Brief Title
Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery.
Official Title
Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery. A Double-blind, Randomised, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Third Molar Extraction Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxilan
Arm Type
Experimental
Arm Description
Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day.
Intervention Type
Drug
Intervention Name(s)
Amoxilan
Intervention Description
Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients receive 8 capsules placebo perioperatively and for the next 3 days 6 capsules per day
Primary Outcome Measure Information:
Title
Mouth opening restrictions: Change of interincisal distance
Description
Interincisal distance, with maximum mouth opening, is measured with a ruler.
Time Frame
preoperatively as well as on the 1st and 7th postoperative day
Secondary Outcome Measure Information:
Title
Change of swelling
Description
Swelling in the cheek area will be determined using a tape measure and 3D photographs.
Time Frame
preoperatively as well as on the 1st and 7th postoperative day
Title
Change of Visual Analogue Scale (VAS): Bleeding
Description
Patients indicate bleeding symptoms on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome
Time Frame
day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Title
Change of Visual Analogue Scale (VAS): Swelling
Description
Patients indicate swelling on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome
Time Frame
day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Title
Change of Visual Analogue Scale (VAS): Pain
Description
Patients indicate pain on a VAS scale, ranging from 0-10, whereas higher values indicate a worse outcome
Time Frame
day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie
City
Graz
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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