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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05142449

Enrollment

Registered

2021-12-02

Start date

2019-03-25

Completion date

2022-09-01

Last updated

2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Third Molar Extraction Surgery

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.

Interventions

DRUGAmoxilan

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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): 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): 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): 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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026