HealthyPhase 4NCT06613776
Evaluation of the Effect of Antibiotic Prophylaxis (2g Amoxicillin One Hour Before Surgery) on an Inflammatory Factor (PGE2) in Salivary Samples After Third Molars Surgery
A Phase 4 study testing Amoxicillin in people with Healthy and Third Molar Extraction Surgery, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
This clinical trial aims to evaluate the impact of antibiotics on inflammation and pain in patients who have undergone mandibular third molar surgery. The primary research questions are: 1. Do antibiotics reduce pain following third molar surgery? 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Third Molar Extraction Surgery, Antibiotic Prophylaxis
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2023to 25 Jul 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy people (ASA I \& II)
- Older than 18 years
- No history of viral or microbial diseases during the last four months
- No history of allergic reaction to penicillin-class antibiotics or other drugs that will be used during the research
- No history of anti-inflammatory or contraceptive drugs use during the last month
- Not being in pregnancy or nursing period for women
- Having at least one unerupted mandibular wisdom tooth needs surgical intervention
Who cannot join
- History of dental pain, inflammation, or abscess during the last month
- thyroid hormone therapy
- unwillingness to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
UCAM dental, Clinica odontologica universitaria
Murcia, Murcia, 30008
About this study
Official title: Evaluation of the Effect of Antibiotic Prophylaxis on Inflammatory Factor in Salivary Samples After Third Molars Surgery
This clinical trial aims to evaluate the impact of antibiotics on inflammation and pain in patients who have undergone mandibular third molar surgery. The primary research questions are:
- Do antibiotics reduce pain following third molar surgery?
- Do antibiotics influence facial swelling and the patient\'s ability to open their mouth?
- Do antibiotics affect the levels of a specific inflammatory marker in saliva post-surgery?
Read more
Participants will be randomly assigned to receive either antibiotic capsules or placebo capsules. The study will include the following procedures:
Medication: Participants will take four capsules (either antibiotics or placebo) as part of their standard surgical care.
Saliva Samples: Saliva samples will be collected at three time points: before surgery, 24 hours after surgery, and 7 days post-surgery.
Measurements: Facial swelling and mouth opening will be assessed by the investigator at each time point.
By comparing the outcomes between the antibiotic and placebo groups, researchers aim to determine the effectiveness of antibiotics in managing post-surgical inflammation and pain.
- Being tested
- Amoxicillin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
4 capsules of amoxicillin 500mg, 2 grams in total, one hour before surgery
PlaceboDrug
4 empty capsules of amoxicillin 500mg (placebo), one hour before surgery
| Study group | Role | What they receive |
|---|---|---|
| intervention group (Antibiotic) | Experimental | 4 amoxicillin 500 mg capsules (2 grams) Receives: Drug: Amoxicillin |
| Control group (Placebo) | Placebo comparator | 4 empty amoxicillin 500mg capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reported by patients
Pain levels are assessed using a Visual Analog Scale (VAS) and a 10-point scale at several intervals: immediately after surgery, at 6 hours, 12 hours, and 24 hours post-surgery, and daily at 17:00 until the 6th day post-surgery. On this scale, 0 indicates no pain, while 10 represents the worst pain the patient has ever experienced.
Measured: From the first visit immediately after surgery to the last visit, 6 days.
Secondary outcomes (2)
Maximum mouth opening change
Using a metal ruler, measure the maximum distance (in millimeters) between the incisal edge of the maxillary incisor and the lower incisor. The researcher will evaluate the maximum mouth opening at four time points: before surgery, immediately after surgery, 24 hours post-surgery, and 7 days post-surgery. The change in maximum mouth opening will be calculated by comparing the pre-surgery measurement with each subsequent measurement. Fewer changes are favorable.
Measured: From the initial visit before surgery to the final visit 7 days post-surgery, at 7 days
Facial swelling
Facial swelling is assessed using a tape-measuring method. The patient sits upright at a 90˚ angle with their mandible at rest. Three facial measurements are taken:
Line A: Distance from the tragus to the corner of the mouth Line B: Distance from the tragus to the soft tissue pogonion Line C: Distance from the outer corner of the eye to the angle of the mandible The facial measurement formula is ((A + B + C) / 3). Facial swelling (%) is calculated as ([postoperative measurement on T2 - preoperative measurement]/preoperative measurement) *100 Less facial swelling is favorable.
Measured: From the day of surgery to the last visit, at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start5 Oct 2023
- Primary completion27 May 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Pérez-Albacete Martínez, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613776
- Sponsor's protocol ID
- CE032315
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) underlying the results in a publication will be shared, ensuring the protection of patients' personal information.
Publications
Torof E, Morrissey H, Ball PA. The Role of Antibiotic Use in Third Molar Tooth Extractions: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2023 Feb 21;59(3):422. doi: 10.3390/medicina59030422.
PubMed 36984426Mehra P, Reebye U, Nadershah M, Cottrell D. Efficacy of anti-inflammatory drugs in third molar surgery: a randomized clinical trial. Int J Oral Maxillofac Surg. 2013 Jul;42(7):835-42. doi: 10.1016/j.ijom.2013.02.017. Epub 2013 Mar 25.
PubMed 23535007
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Antibiotic Prophylaxis on Inflammatory Factor in Salivary Samples After Third Molars Surgery
- ClinicalTrials.gov ID
- NCT06613776
- Acronym / sponsor ID
- CE032315
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 26 Sep 2024 (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.
This clinical trial aims to evaluate the impact of antibiotics on inflammation and pain in patients who have undergone mandibular third molar surgery. The primary research questions are:
- Do antibiotics reduce pain following third molar surgery?
- Do antibiotics influence facial swelling and the patient\'s ability to open their mouth?
- Do antibiotics affect the levels of a specific inflammatory marker in saliva post-surgery?
Participants will be randomly assigned to receive either antibiotic capsules or placebo capsules. The study will include the following procedures:
Medication: Participants will take four capsules (either antibiotics or placebo) as part of their standard surgical care.
Saliva Samples: Saliva samples will be collected at three time points: before surgery, 24 hours after surgery, and 7 days post-surgery.
Measurements: Facial swelling and mouth opening will be assessed by the investigator at each time point.
By comparing the outcomes between the antibiotic and placebo groups, researchers aim to determine the effectiveness of antibiotics in managing post-surgical inflammation and pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group (Antibiotic) | Experimental | Drug: Amoxicillin4 amoxicillin 500 mg capsules (2 grams) |
| Control group (Placebo) | Placebo comparator | Drug: Placebo4 empty amoxicillin 500mg capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy people (ASA I \& II)
- Older than 18 years
- No history of viral or microbial diseases during the last four months
- No history of allergic reaction to penicillin-class antibiotics or other drugs that will be used during the research
- No history of anti-inflammatory or contraceptive drugs use during the last month
Key exclusion criteria (3 listed)
- History of dental pain, inflammation, or abscess during the last month
- thyroid hormone therapy
- unwillingness to participate in the study.
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 |
|---|---|---|
| Amoxicillin4 capsules of amoxicillin 500mg, 2 grams in total, one hour before surgery | Drug | intervention group (Antibiotic) |
| Placebo4 empty capsules of amoxicillin 500mg (placebo), one hour before surgery | Drug | Control group (Placebo) |
Primary outcome
Pain reported by patients
Time frame: From the first visit immediately after surgery to the last visit, 6 days.
Pain levels are assessed using a Visual Analog Scale (VAS) and a 10-point scale at several intervals: immediately after surgery, at 6 hours, 12 hours, and 24 hours post-surgery, and daily at 17:00 until the 6th day post-surgery. On this scale, 0 indicates no pain, while 10 represents the worst pain the patient has ever experienced.
2 secondary outcomes
Maximum mouth opening change
Time frame: From the initial visit before surgery to the final visit 7 days post-surgery, at 7 days
Facial swelling
Time frame: From the day of surgery to the last visit, at 7 days
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 26 Sep 2024.
- Background: PubMed 36984426Torof E, Morrissey H, Ball PA. The Role of Antibiotic Use in Third Molar Tooth Extractions: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2023 Feb 21;59(3):422. doi: 10.3390/medicina59030422.
- Background: PubMed 23535007Mehra P, Reebye U, Nadershah M, Cottrell D. Efficacy of anti-inflammatory drugs in third molar surgery: a randomized clinical trial. Int J Oral Maxillofac Surg. 2013 Jul;42(7):835-42. doi: 10.1016/j.ijom.2013.02.017. Epub 2013 Mar 25.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) underlying the results in a publication will be shared, ensuring the protection of patients' personal information.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Amoxicillin in people with Healthy and Third Molar Extraction Surgery, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 7 inclusion and 3 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 26 Sep 2024. 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 Spain. 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?
Pain reported by patients (time frame: From the first visit immediately after surgery to the last visit, 6 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06613776, which also lists 2 linked publications.
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 26 Sep 2024.