Third Molar Extraction SurgeryPhase 4NCT05142449
Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery.
A Phase 4 study testing Amoxilan in people with Third Molar Extraction Surgery, run by Medical University of Graz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Third Molar Extraction Surgery
- What is being tested?
- Amoxilan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteAustria
- Study dates
- 25 Mar 2019to 1 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptom-free, bilaterally located third molars
- Medically healthy patient ≥ 16 years
- No allergies/intolerances against the investigational product/placebo
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie
Graz, 8010
About this study
Official title: Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery. A Double-blind, Randomised, Placebo-controlled Trial
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
- Being tested
- Amoxilan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxilanDrug
Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day
PlaceboOther
Patients receive 8 capsules placebo perioperatively and for the next 3 days 6 capsules per day
| Study group | Role | What they receive |
|---|---|---|
| Amoxilan | Experimental | Patients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day. Receives: Drug: Amoxilan |
| Placebo | Placebo comparator | Patients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth opening restrictions: Change of interincisal distance
Interincisal distance, with maximum mouth opening, is measured with a ruler.
Measured: preoperatively as well as on the 1st and 7th postoperative day
Secondary outcomes (4)
Change of swelling
Swelling in the cheek area will be determined using a tape measure and 3D photographs.
Measured: preoperatively as well as on the 1st and 7th postoperative day
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
Measured: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
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
Measured: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
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
Measured: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start25 Mar 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Molar Extraction SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142449
- Sponsor's protocol ID
- AMOXI
- Status last verified
- Oct 2022
- First submitted
- 24 Nov 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery. A Double-blind, Randomised, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05142449
- Acronym / sponsor ID
- AMOXI
- Conditions
- Third Molar Extraction Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxilan | Experimental | Drug: AmoxilanPatients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day. |
| Placebo | Placebo comparator | Other: PlaceboPatients receive 8 capsules Placebo perioperatively and for the next 3 days 6 capsules per day. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Symptom-free, bilaterally located third molars
- Medically healthy patient ≥ 16 years
- No allergies/intolerances against the investigational product/placebo
- Informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmoxilanPatients receive 8 capsules Amoxilan perioperatively and for the next 3 days 6 capsules per day | Drug | Amoxilan |
| PlaceboPatients receive 8 capsules placebo perioperatively and for the next 3 days 6 capsules per day | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Change of swelling
Time frame: preoperatively as well as on the 1st and 7th postoperative day
Change of Visual Analogue Scale (VAS): Bleeding
Time frame: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Change of Visual Analogue Scale (VAS): Swelling
Time frame: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Change of Visual Analogue Scale (VAS): Pain
Time frame: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxilan in people with Third Molar Extraction Surgery, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth opening restrictions: Change of interincisal distance (time frame: preoperatively as well as on the 1st and 7th postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.