Impacted Lower Third MolarPhase 4NCT07817940
Antibiotic Therapy in Impacted Mandibular Third Molar Surgery
A Phase 4 study testing Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet in people with Impacted Lower Third Molar, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study compared three antibiotic approaches in healthy young adults undergoing surgical removal of impacted lower wisdom teeth: a single dose of antibiotics before surgery, antibiotic treatment after surgery, and no antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Lower Third Molar
- What is being tested?
- Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Nov 2023to 26 Dec 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
- Age 18 years or older Systemically healthy status Presence of bilateral, symmetrical, asymptomatic impacted mandibular third molars classified as Pell and Gregory Class II, Position B No antibiotic use within the 4 weeks preceding surgery Ability and willingness to provide written informed consent
Who cannot join
- Uncontrolled systemic disease Pregnancy or lactation Active pericoronal infection History of allergy to amoxicillin, clavulanic acid, or articaine hydrochloride Presence of local pathology at the surgical site Previous radiotherapy to the head and neck region Syndromic conditions Any postoperative complication following the first surgery that prevented completion of the second surgical procedure according to the study protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University, Faculty of Dentistry
Bolu, Bolu, 14030
About this study
Official title: Effects of Preoperative and Postoperative Antibiotic Therapy on Clinical Outcomes and Systemic Inflammatory Biomarkers Following Impacted Mandibular Third Molar Surgery: A Prospective Randomized Double-Blind Split-Mouth Trial
This study compared three antibiotic approaches in healthy young adults undergoing surgical removal of impacted lower wisdom teeth: a single dose of antibiotics before surgery, antibiotic treatment after surgery, and no antibiotics. Participants had similar impacted lower wisdom teeth on both sides and underwent surgery in two separate sessions. The study evaluated postoperative pain, facial swelling, mouth opening, and changes in blood markers related to inflammation, including C-reactive protein, erythrocyte sedimentation rate, procalcitonin, and white blood cell counts. The aim was to determine whether antibiotic use before or after surgery affected postoperative recovery and systemic inflammatory responses compared with no antibiotic use.
Read the detailed description
This prospective randomized study included 30 systemically healthy young adults with bilaterally symmetrical, asymptomatic impacted mandibular third molars classified as Pell and Gregory Class II, Position B. Each participant underwent two surgical procedures, performed four weeks apart by the same surgeon. Three antibiotic strategies were evaluated: a single preoperative antibiotic dose, postoperative antibiotic therapy, and no antibiotic treatment. Because each participant received two of the three interventions, participants were assigned to one of three treatment sequences. Clinical outcomes, including postoperative pain, facial swelling, and maximum mouth opening, were assessed during follow-up. Blood samples were collected before surgery and on postoperative days 1, 3, and 7 to evaluate systemic inflammatory biomarkers, including C-reactive protein, erythrocyte sedimentation rate, procalcitonin, and white blood cell parameters.
- Conditions
- Impacted Lower Third Molar
- Being tested
- Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
- Keywords
- Procalcitonin, antibiotic prophylaxis, C-reactive protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral TabletDrug
Amoxicillin-clavulanate 875/125 mg was administered twice daily for 7 days after surgery.
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral TabletDrug
A single 2 g dose of amoxicillin-clavulanate was administered preoperatively as antibiotic prophylaxis before impacted mandibular third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Antibiotic | Experimental | Participants received a single 2 g dose of amoxicillin-clavulanate before impacted mandibular third molar surgery. Receives: Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet |
| Postoperative Antibiotic | Active comparator | Participants received amoxicillin-clavulanate 875/125 mg twice daily for 7 days after impacted mandibular third molar surgery Receives: Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet |
| No Antibiotic | No intervention | Participants underwent impacted mandibular third molar surgery without preoperative or postoperative antibiotic treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum C-Reactive Protein (CRP) Level
Serum C-reactive protein (CRP) levels were measured to assess the systemic inflammatory response following impacted mandibular third molar surgery and to compare the effects of preoperative antibiotic prophylaxis, postoperative antibiotic therapy, and no antibiotic therapy. CRP levels were measured using an Architect c16000 automated analyzer (Abbott Laboratories, Abbott Park, IL, USA).
Measured: Baseline (preoperative) and postoperative days 1, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start14 Nov 2023
- Primary completion26 Dec 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Lower Third MolarStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants underwent two surgical sessions, four weeks apart, and received two of the three antibiotic strategies according to a randomized balanced incomplete-block crossover design with a split-mouth component.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ömerfarukboylu, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817940
- Sponsor's protocol ID
- AIBU-DH-OFB-01
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no IPD sharing plan was established as part of the original study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative and Postoperative Antibiotic Therapy on Clinical Outcomes and Systemic Inflammatory Biomarkers Following Impacted Mandibular Third Molar Surgery: A Prospective Randomized Double-Blind Split-Mouth Trial
- ClinicalTrials.gov ID
- NCT07817940
- Acronym / sponsor ID
- AIBU-DH-OFB-01
- Conditions
- Impacted Lower Third Molar
- Keywords
- Procalcitonin, antibiotic prophylaxis, C-reactive protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 14 Sep 2026 (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 study compared three antibiotic approaches in healthy young adults undergoing surgical removal of impacted lower wisdom teeth: a single dose of antibiotics before surgery, antibiotic treatment after surgery, and no antibiotics. Participants had similar impacted lower wisdom teeth on both sides and underwent surgery in two separate sessions. The study evaluated postoperative pain, facial swelling, mouth opening, and changes in blood markers related to inflammation, including C-reactive protein, erythrocyte sedimentation rate, procalcitonin, and white blood cell counts. The aim was to determine whether antibiotic use before or after surgery affected postoperative recovery and systemic inflammatory responses compared with no antibiotic use.
Detailed description
This prospective randomized study included 30 systemically healthy young adults with bilaterally symmetrical, asymptomatic impacted mandibular third molars classified as Pell and Gregory Class II, Position B. Each participant underwent two surgical procedures, performed four weeks apart by the same surgeon. Three antibiotic strategies were evaluated: a single preoperative antibiotic dose, postoperative antibiotic therapy, and no antibiotic treatment. Because each participant received two of the three interventions, participants were assigned to one of three treatment sequences. Clinical outcomes, including postoperative pain, facial swelling, and maximum mouth opening, were assessed during follow-up. Blood samples were collected before surgery and on postoperative days 1, 3, and 7 to evaluate systemic inflammatory biomarkers, including C-reactive protein, erythrocyte sedimentation rate, procalcitonin, and white blood cell parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Participants underwent two surgical sessions, four weeks apart, and received two of the three antibiotic strategies according to a randomized balanced incomplete-block crossover design with a split-mouth component.
| Arm | Type | Receives |
|---|---|---|
| Preoperative Antibiotic | Experimental | Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral TabletParticipants received a single 2 g dose of amoxicillin-clavulanate before impacted mandibular third molar surgery. |
| Postoperative Antibiotic | Active comparator | Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral TabletParticipants received amoxicillin-clavulanate 875/125 mg twice daily for 7 days after impacted mandibular third molar surgery |
| No Antibiotic | No intervention | –Participants underwent impacted mandibular third molar surgery without preoperative or postoperative antibiotic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or older Systemically healthy status Presence of bilateral, symmetrical, asymptomatic impacted mandibular third molars classified as Pell and Gregory Class II, Position B No antibiotic use within the 4 weeks preceding surgery Ability and willingness to provide written informed consent
Key exclusion criteria (1 listed)
- Uncontrolled systemic disease Pregnancy or lactation Active pericoronal infection History of allergy to amoxicillin, clavulanic acid, or articaine hydrochloride Presence of local pathology at the surgical site Previous radiotherapy to the head and neck region Syndromic conditions Any postoperative complication following the first surgery that prevented completion of the second surgical procedure according to the study protocol
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 |
|---|---|---|
| Amoxicillin-Clavulanate 875 Mg-125 Mg Oral TabletAmoxicillin-clavulanate 875/125 mg was administered twice daily for 7 days after surgery. | Drug | Postoperative Antibiotic |
| Amoxicillin-Clavulanate 875 Mg-125 Mg Oral TabletA single 2 g dose of amoxicillin-clavulanate was administered preoperatively as antibiotic prophylaxis before impacted mandibular third molar surgery. | Drug | Preoperative Antibiotic |
Primary outcome
Change in Serum C-Reactive Protein (CRP) Level
Time frame: Baseline (preoperative) and postoperative days 1, 3, and 7
Serum C-reactive protein (CRP) levels were measured to assess the systemic inflammatory response following impacted mandibular third molar surgery and to compare the effects of preoperative antibiotic prophylaxis, postoperative antibiotic therapy, and no antibiotic therapy. CRP levels were measured using an Architect c16000 automated analyzer (Abbott Laboratories, Abbott Park, IL, USA).
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no IPD sharing plan was established as part of the original study protocol.
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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 Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet in people with Impacted Lower Third Molar, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 14 Sep 2026. 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 Turkey (Türkiye). 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. 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?
Change in Serum C-Reactive Protein (CRP) Level (time frame: Baseline (preoperative) and postoperative days 1, 3, and 7). 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 14 Sep 2026.