Impacted Mandibular Third MolarNCT07857863
Preoperative Versus Postoperative Amoxicillin in Impacted Third Molar Surgery
An observational study of Impacted Mandibular Third Molar and Impacted Mandibular Third Molar Extraction, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study evaluated the effects of the timing of amoxicillin use on postoperative recovery and oral health-related quality of life following impacted mandibular third molar surgery. A total of 52 healthy adults aged 18-50 years were included. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Impacted Mandibular Third Molar, Impacted Mandibular Third Molar Extraction
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2026to 29 Sep 2026
- Phase
- Observational
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults aged 18-50 years presenting to the Department of Oral and Maxillofacial Surgery at Recep Tayyip Erdoğan University Faculty of Dentistry with an impacted mandibular third molar indicated for surgical removal and meeting the prespecified clinical and radiographic eligibility criteria.
Who may be able to join
- Age between 18 and 50 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Presence of an impacted mandibular third molar with an indication for surgical removal
- Pell and Gregory Class II according to the relationship between the mandibular ramus and the second molar
- Pell and Gregory Level A according to impaction depth
- Mesioangular, bone-retained mandibular third molar (FDI tooth 38 or 48) according to Winter's classification
Who cannot join
- Age younger than 18 years
- Current smoking or alcohol use
- Presence of a coagulation disorder
- Presence of any disease that may impair wound healing or use of medication for such a condition
- Pregnancy or lactation
- Presence of pericoronitis associated with the impacted tooth
Show all 10Show fewer
- Presence of pathology associated with the impacted tooth
- Inability to complete the scheduled postoperative follow-up
- Presence of uncontrolled periodontal disease in the oral cavity
- Known allergy to any medication used in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry
Rize, Rize Province, 53020
About this study
Official title: A Comparative Evaluation of the Effects of Preoperative and Postoperative Amoxicillin Use on Postoperative Recovery and Quality of Life Following Impacted Third Molar Surgery
This prospective observational cohort study evaluated the effects of the timing of amoxicillin use on postoperative recovery and oral health-related quality of life following impacted mandibular third molar surgery. A total of 52 healthy adults aged 18-50 years were included. Participants were classified into two cohorts according to the amoxicillin regimen selected by the treating clinician based on clinical assessment: preoperative amoxicillin, initiated 3 days before surgery and continued for a total of 5 days, or postoperative amoxicillin, initiated on the day of surgery and continued for 5 days. In both cohorts, amoxicillin was administered at a dose of 1000 mg twice daily. Postoperative pain, facial swelling, maximum mouth opening, and oral health-related quality of life were assessed. Pain, swelling, and mouth opening were evaluated on postoperative days 1, 3, and 7, and quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) on postoperative day 7. The study aimed to compare postoperative recovery between the two antibiotic-timing approaches.
Read the detailed description
Surgical removal of impacted mandibular third molars is commonly associated with postoperative pain, swelling, limitation of mouth opening, and temporary impairment in quality of life. Although systemic antibiotics are frequently used around third molar surgery, the optimal timing of antibiotic administration remains uncertain.
This prospective observational cohort study compared postoperative recovery in patients receiving amoxicillin according to two different clinical timing approaches. Participants were not randomized, and the antibiotic regimen was determined by the treating clinician according to clinical assessment and suitability. Patients were subsequently classified into a preoperative amoxicillin cohort or a postoperative amoxicillin cohort.
Participants in the preoperative cohort received amoxicillin 1000 mg twice daily beginning 3 days before surgery and continuing for a total of 5 days. Participants in the postoperative cohort received amoxicillin 1000 mg twice daily beginning on the day of surgery and continuing for 5 days.
Postoperative pain was assessed using a visual analog scale on days 1, 3, and 7 after surgery. Facial swelling was evaluated using standardized facial measurements obtained preoperatively and on postoperative days 1, 3, and 7. Maximum mouth opening was measured as the interincisal distance before surgery and on postoperative days 1, 3, and 7 to assess postoperative trismus. Oral health-related quality of life was evaluated on postoperative day 7 using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14).
The primary objective was to determine whether the timing of amoxicillin administration was associated with differences in postoperative recovery following impacted mandibular third molar surgery.
- Being tested
- Amoxicillin
- Keywords
- Amoxicillin, Third Molar Surgery, Antibiotic Prophylaxis, Postoperative Pain, Facial Swelling, Trismus, Oral Health-Related Quality of Life, OHIP-14
- Medical subject headings
- Pain, Postoperative, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Oral amoxicillin 1000 mg administered twice daily. In the preoperative cohort, treatment began 3 days before surgery and continued for a total of 5 days. In the postoperative cohort, treatment began on the day of surgery and continued for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Amoxicillin Cohort | Participants who received amoxicillin 1000 mg twice daily beginning 3 days before impacted mandibular third molar surgery and continuing for a total of 5 days. The antibiotic regimen was determined by the treating clinician based on clinical assessment. Receives: Drug: Amoxicillin | |
| Postoperative Amoxicillin Cohort | Participants who received amoxicillin 1000 mg twice daily beginning on the day of impacted mandibular third molar surgery and continuing for 5 days. The antibiotic regimen was determined by the treating clinician based on clinical assessment. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity From Baseline
Pain intensity was assessed using a 0-10 visual analog scale (VAS), where 0 indicated no pain and 10 indicated the maximum pain experienced by the participant. Pain was evaluated preoperatively and on postoperative days 1, 3, and 7. Higher scores indicate greater pain intensity.
Measured: Baseline (preoperative) and Postoperative Days 1, 3, and 7
Change in Facial Swelling From Baseline
Facial swelling was assessed using the sum of five standardized facial measurements: tragus-commissura labiorum, tragus-nasolabial sulcus, tragus-pogonion, mandibular angle-lateral canthus, and commissura labiorum-lateral canthus. Measurements were obtained preoperatively and on postoperative days 1, 3, and 7 using a flexible ruler. Higher total measurements indicate greater facial swelling.
Measured: Baseline (preoperative) and Postoperative Days 1, 3, and 7
Change in Maximum Mouth Opening From Baseline
Maximum mouth opening was measured in millimeters as the interincisal distance between the incisal edges of the upper and lower central incisors during maximum unassisted mouth opening. Measurements were obtained preoperatively and on postoperative days 1, 3, and 7. Lower values indicate greater limitation of mouth opening (trismus).
Measured: Baseline (preoperative) and Postoperative Days 1, 3, and 7
Oral Health-Related Quality of Life Assessed by OHIP-14
Oral health-related quality of life was assessed using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). Each item was scored from 0 (never) to 4 (very often), with higher total scores indicating greater oral health-related impairment.
Measured: Postoperative Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start10 Apr 2026
- Primary completion28 Sep 2026
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Gumrukcu, Recep Tayyip Erdogan University
- Investigators
- Zeynep Gümrükçü, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857863
- Sponsor's protocol ID
- 2026/193
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared with other researchers. Study findings will be reported in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Effects of Preoperative and Postoperative Amoxicillin Use on Postoperative Recovery and Quality of Life Following Impacted Third Molar Surgery
- ClinicalTrials.gov ID
- NCT07857863
- Acronym / sponsor ID
- 2026/193
- Keywords
- Amoxicillin, Third Molar Surgery, Antibiotic Prophylaxis, Postoperative Pain, Facial Swelling, Trismus, Oral Health-Related Quality of Life, OHIP-14
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 5 Oct 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 prospective observational cohort study evaluated the effects of the timing of amoxicillin use on postoperative recovery and oral health-related quality of life following impacted mandibular third molar surgery. A total of 52 healthy adults aged 18-50 years were included. Participants were classified into two cohorts according to the amoxicillin regimen selected by the treating clinician based on clinical assessment: preoperative amoxicillin, initiated 3 days before surgery and continued for a total of 5 days, or postoperative amoxicillin, initiated on the day of surgery and continued for 5 days. In both cohorts, amoxicillin was administered at a dose of 1000 mg twice daily. Postoperative pain, facial swelling, maximum mouth opening, and oral health-related quality of life were assessed. Pain, swelling, and mouth opening were evaluated on postoperative days 1, 3, and 7, and quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14) on postoperative day 7. The study aimed to compare postoperative recovery between the two antibiotic-timing approaches.
Detailed description
Surgical removal of impacted mandibular third molars is commonly associated with postoperative pain, swelling, limitation of mouth opening, and temporary impairment in quality of life. Although systemic antibiotics are frequently used around third molar surgery, the optimal timing of antibiotic administration remains uncertain.
This prospective observational cohort study compared postoperative recovery in patients receiving amoxicillin according to two different clinical timing approaches. Participants were not randomized, and the antibiotic regimen was determined by the treating clinician according to clinical assessment and suitability. Patients were subsequently classified into a preoperative amoxicillin cohort or a postoperative amoxicillin cohort.
Participants in the preoperative cohort received amoxicillin 1000 mg twice daily beginning 3 days before surgery and continuing for a total of 5 days. Participants in the postoperative cohort received amoxicillin 1000 mg twice daily beginning on the day of surgery and continuing for 5 days.
Postoperative pain was assessed using a visual analog scale on days 1, 3, and 7 after surgery. Facial swelling was evaluated using standardized facial measurements obtained preoperatively and on postoperative days 1, 3, and 7. Maximum mouth opening was measured as the interincisal distance before surgery and on postoperative days 1, 3, and 7 to assess postoperative trismus. Oral health-related quality of life was evaluated on postoperative day 7 using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14).
The primary objective was to determine whether the timing of amoxicillin administration was associated with differences in postoperative recovery following impacted mandibular third molar surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Amoxicillin Cohort | – | Drug: AmoxicillinParticipants who received amoxicillin 1000 mg twice daily beginning 3 days before impacted mandibular third molar surgery and continuing for a total of 5 days. The antibiotic regimen was determined by the treating clinician based on clinical assessment. |
| Postoperative Amoxicillin Cohort | – | Drug: AmoxicillinParticipants who received amoxicillin 1000 mg twice daily beginning on the day of impacted mandibular third molar surgery and continuing for 5 days. The antibiotic regimen was determined by the treating clinician based on clinical assessment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults aged 18-50 years presenting to the Department of Oral and Maxillofacial Surgery at Recep Tayyip Erdoğan University Faculty of Dentistry with an impacted mandibular third molar indicated for surgical removal and meeting the prespecified clinical and radiographic eligibility criteria.
Key inclusion criteria (6 listed)
- Age between 18 and 50 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Presence of an impacted mandibular third molar with an indication for surgical removal
- Pell and Gregory Class II according to the relationship between the mandibular ramus and the second molar
- Pell and Gregory Level A according to impaction depth
Key exclusion criteria (10 listed)
- Age younger than 18 years
- Current smoking or alcohol use
- Presence of a coagulation disorder
- Presence of any disease that may impair wound healing or use of medication for such a condition
- Pregnancy or lactation
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 |
|---|---|---|
| AmoxicillinOral amoxicillin 1000 mg administered twice daily. In the preoperative cohort, treatment began 3 days before surgery and continued for a total of 5 days. In the postoperative cohort, treatment began on the day of surgery and continued for 5 days. | Drug | Postoperative Amoxicillin Cohort, Preoperative Amoxicillin Cohort |
Primary outcome
Change in Pain Intensity From Baseline
Time frame: Baseline (preoperative) and Postoperative Days 1, 3, and 7
Pain intensity was assessed using a 0-10 visual analog scale (VAS), where 0 indicated no pain and 10 indicated the maximum pain experienced by the participant. Pain was evaluated preoperatively and on postoperative days 1, 3, and 7. Higher scores indicate greater pain intensity.
Change in Facial Swelling From Baseline
Time frame: Baseline (preoperative) and Postoperative Days 1, 3, and 7
Facial swelling was assessed using the sum of five standardized facial measurements: tragus-commissura labiorum, tragus-nasolabial sulcus, tragus-pogonion, mandibular angle-lateral canthus, and commissura labiorum-lateral canthus. Measurements were obtained preoperatively and on postoperative days 1, 3, and 7 using a flexible ruler. Higher total measurements indicate greater facial swelling.
Change in Maximum Mouth Opening From Baseline
Time frame: Baseline (preoperative) and Postoperative Days 1, 3, and 7
Maximum mouth opening was measured in millimeters as the interincisal distance between the incisal edges of the upper and lower central incisors during maximum unassisted mouth opening. Measurements were obtained preoperatively and on postoperative days 1, 3, and 7. Lower values indicate greater limitation of mouth opening (trismus).
Oral Health-Related Quality of Life Assessed by OHIP-14
Time frame: Postoperative Day 7
Oral health-related quality of life was assessed using the Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). Each item was scored from 0 (never) to 4 (very often), with higher total scores indicating greater oral health-related impairment.
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 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared with other researchers. Study findings will be reported in aggregate form.
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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.
Zeynep Gümrükçü principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Mandibular Third Molar and Impacted Mandibular Third Molar Extraction, run by Recep Tayyip Erdogan 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 6 inclusion and 10 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 5 Oct 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.
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 Pain Intensity From Baseline (time frame: Baseline (preoperative) and Postoperative Days 1, 3, and 7). The study lists 4 primary outcomes in all. 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 5 Oct 2026.