Impacted ToothPhase 4POTA-M3SNCT07573033
Effectiveness of Postoperative Topical and Oral Antibiotics on Impacted Mandibular 3rd Molar Surgery.
A Phase 4 study testing Topical Antibiotic and Oral antibiotic therapy in people with Impacted Tooth and Postoperative Complications in Maxillofacial Surgery, run by Liaquat College of Medicine and Dentistry at 1 site in Pakistan.
Trial summary
This randomized controlled trial evaluates the effectiveness of postoperative topical antibiotics compared with oral antibiotics in patients undergoing surgical extraction of impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Impacted Tooth, Postoperative Complications in Maxillofacial Surgery, Surgical Wound Infection
- What is being tested?
- Topical Antibiotic and Oral antibiotic therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 30 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged 18-40 years.
- Patients scheduled for surgical extraction of impacted mandibular third molars.
- Presence of pain, infection, or impaction requiring extraction.
- Fully or partially impacted mandibular third molars.
- Pell and Gregory Class II or Class III impaction.
- Medically fit for surgical procedures and antibiotic therapy.
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- Provided written informed consent. Exclusion Criteria
- Known allergy to antibiotics.
- Known allergy to local anesthetic agents.
- Previous surgery in the same anatomical area.
- Poor oral hygiene.
- Active oral infections.
- Presence of systemic illness contraindicating surgery or antibiotic use.
- Pregnant women.
- Breastfeeding women.
- Inability to attend follow-up visits.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Postoperative Topical and Oral Antibiotics on Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
This randomized controlled trial evaluates the effectiveness of postoperative topical antibiotics compared with oral antibiotics in patients undergoing surgical extraction of impacted mandibular third molars. The study aims to compare postoperative outcomes including infection, dry socket, pain, swelling, recovery time, patient satisfaction, and adverse effects associated with antibiotic use. A total of 90 participants undergoing mandibular third molar surgery will be randomly assigned to receive either topical antibiotic application at the surgical site or a standard postoperative course of oral antibiotics. Participants will be followed for 14 days after surgery with clinical assessments conducted at scheduled follow-up visits.
Detailed Description:
Read more
Impacted mandibular third molar extraction is one of the most commonly performed oral surgical procedures and is frequently associated with postoperative complications such as pain, swelling, infection, and alveolar osteitis (dry socket). Antibiotics are commonly prescribed after third molar surgery to reduce the risk of postoperative infections; however, routine systemic antibiotic use may contribute to adverse drug reactions and antibiotic resistance. Topical antibiotic application at the surgical site may offer localized antimicrobial effects while reducing systemic exposure and related complications.
This study is a two-arm, parallel-group randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The study duration is six months from February 2024 to July 2024. Ethical approval was obtained from the Institutional Review Board of Liaquat College of Medicine and Dentistry (REF.No.IRB/D-000090/24), and written informed consent is obtained from all participants before enrollment.
A total of 90 participants aged 18 to 40 years undergoing surgical extraction of impacted mandibular third molars are enrolled and randomly allocated in a 1:1 ratio into two treatment groups using computerized block randomization with allocation concealment through sequentially numbered opaque sealed envelopes. Participants in the experimental group receive topical antibiotic application directly at the extraction site immediately after surgery, while participants in the comparator group receive a standard 5-day postoperative oral antibiotic regimen according to institutional protocol.
All surgical procedures are performed under local anesthesia using standardized surgical techniques by qualified oral surgeons. Follow-up evaluations are conducted on postoperative days 1, 3, 7, and 14 to assess postoperative outcomes.
The primary outcomes include postoperative infection and dry socket incidence. Secondary outcomes include postoperative pain measured using a Visual Analog Scale (VAS), facial swelling, patient satisfaction, recovery time, and adverse effects related to antibiotic therapy.
Data are analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics are used to summarize demographic and clinical variables. Comparative analyses between groups are performed using appropriate statistical tests, including chi-square tests for categorical variables, with a p-value of less than 0.05 considered statistically significant.
Read the detailed description
Impacted mandibular third molar extraction is one of the most commonly performed oral surgical procedures and is frequently associated with postoperative complications such as pain, swelling, infection, and alveolar osteitis (dry socket). Antibiotics are commonly prescribed after third molar surgery to reduce the risk of postoperative infections; however, routine systemic antibiotic use may contribute to adverse drug reactions and antibiotic resistance. Topical antibiotic application at the surgical site may offer localized antimicrobial effects while reducing systemic exposure and related complications.
This study is a two-arm, parallel-group randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The study duration is six months from February 2024 to July 2024. Ethical approval was obtained from the Institutional Review Board of Liaquat College of Medicine and Dentistry (REF.No.IRB/D-000090/24), and written informed consent is obtained from all participants before enrollment.
A total of 90 participants aged 18 to 40 years undergoing surgical extraction of impacted mandibular third molars are enrolled and randomly allocated in a 1:1 ratio into two treatment groups using computerized block randomization with allocation concealment through sequentially numbered opaque sealed envelopes. Participants in the experimental group receive topical antibiotic application directly at the extraction site immediately after surgery, while participants in the comparator group receive a standard 5-day postoperative oral antibiotic regimen according to institutional protocol.
All surgical procedures are performed under local anesthesia using standardized surgical techniques by qualified oral surgeons. Follow-up evaluations are conducted on postoperative days 1, 3, 7, and 14 to assess postoperative outcomes.
The primary outcomes include postoperative infection and dry socket incidence. Secondary outcomes include postoperative pain measured using a Visual Analog Scale (VAS), facial swelling, patient satisfaction, recovery time, and adverse effects related to antibiotic therapy.
Data are analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics are used to summarize demographic and clinical variables. Comparative analyses between groups are performed using appropriate statistical tests, including chi-square tests for categorical variables, with a p-value of less than 0.05 considered statistically significant.
- Conditions
- Impacted Tooth, Postoperative Complications in Maxillofacial Surgery, Surgical Wound Infection, Facial Pain
- Being tested
- Topical Antibiotic, Oral antibiotic therapy
- Keywords
- Dry Socket, Mandibular Third Molar, Oral Antibiotics, Postoperative Infection, Topical Antibiotics
- Medical subject headings
- Tooth, Impacted, Surgical Wound Infection, Facial Pain, Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical AntibioticDrug
Topical antibiotic applied locally to the extraction socket immediately after surgical removal of impacted mandibular third molars.
Oral antibiotic therapyDrug
Standard postoperative oral antibiotic regimen administered for 5 days after surgical extraction of impacted mandibular third molars.
| Study group | Role | What they receive |
|---|---|---|
| Use this module to add descriptions of each arm in the study and to list the interventions being stu | Experimental | Participants received topical antibiotic application directly at the surgical extraction site immediately after impacted mandibular third molar surgery along with standard postoperative instructions. Receives: Drug: Topical Antibiotic |
| Oral Antibiotic Group | Active comparator | Participants received a standard 5-day course of postoperative oral antibiotics following impacted mandibular third molar surgery according to institutional protocol. Receives: Drug: Oral antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Infection
Postoperative infection assessed by the presence of clinical signs including redness, swelling, purulent discharge, or fever at the surgical site following impacted mandibular third molar extraction.
Measured: Within 14 days after surgery
Incidence of Dry Socket (Alveolar Osteitis)
Dry socket assessed by severe postoperative pain associated with partial or complete loss of the blood clot at the extraction site after mandibular third molar surgery.
Measured: Postoperative days 3 to 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Feb 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted ToothStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergoing impacted mandibular third molar surgery will be randomly assigned to parallel groups receiving either postoperative oral antibiotics, topical antibiotics, or standard postoperative care/control to compare postoperative outcomes including pain, infection, inflammation, and dry socket incidence.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat College of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Karim, Liaquat College of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573033
- Sponsor's protocol ID
- 00923002216371
- Acronym
- POTA-M3S
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be shared publicly in order to maintain participant confidentiality and comply with institutional ethical guidelines. Aggregated and anonymized study findings will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Postoperative Topical and Oral Antibiotics on Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07573033
- Acronym / sponsor ID
- POTA-M3S / 00923002216371
- Conditions
- Impacted Tooth, Postoperative Complications in Maxillofacial Surgery, Surgical Wound Infection, Facial Pain
- Keywords
- Dry Socket, Mandibular Third Molar, Oral Antibiotics, Postoperative Infection, Topical Antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Liaquat College of Medicine and DentistryUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 7 May 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 randomized controlled trial evaluates the effectiveness of postoperative topical antibiotics compared with oral antibiotics in patients undergoing surgical extraction of impacted mandibular third molars. The study aims to compare postoperative outcomes including infection, dry socket, pain, swelling, recovery time, patient satisfaction, and adverse effects associated with antibiotic use. A total of 90 participants undergoing mandibular third molar surgery will be randomly assigned to receive either topical antibiotic application at the surgical site or a standard postoperative course of oral antibiotics. Participants will be followed for 14 days after surgery with clinical assessments conducted at scheduled follow-up visits.
Detailed Description:
Impacted mandibular third molar extraction is one of the most commonly performed oral surgical procedures and is frequently associated with postoperative complications such as pain, swelling, infection, and alveolar osteitis (dry socket). Antibiotics are commonly prescribed after third molar surgery to reduce the risk of postoperative infections; however, routine systemic antibiotic use may contribute to adverse drug reactions and antibiotic resistance. Topical antibiotic application at the surgical site may offer localized antimicrobial effects while reducing systemic exposure and related complications.
This study is a two-arm, parallel-group randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The study duration is six months from February 2024 to July 2024. Ethical approval was obtained from the Institutional Review Board of Liaquat College of Medicine and Dentistry (REF.No.IRB/D-000090/24), and written informed consent is obtained from all participants before enrollment.
A total of 90 participants aged 18 to 40 years undergoing surgical extraction of impacted mandibular third molars are enrolled and randomly allocated in a 1:1 ratio into two treatment groups using computerized block randomization with allocation concealment through sequentially numbered opaque sealed envelopes. Participants in the experimental group receive topical antibiotic application directly at the extraction site immediately after surgery, while participants in the comparator group receive a standard 5-day postoperative oral antibiotic regimen according to institutional protocol.
All surgical procedures are performed under local anesthesia using standardized surgical techniques by qualified oral surgeons. Follow-up evaluations are conducted on postoperative days 1, 3, 7, and 14 to assess postoperative outcomes.
The primary outcomes include postoperative infection and dry socket incidence. Secondary outcomes include postoperative pain measured using a Visual Analog Scale (VAS), facial swelling, patient satisfaction, recovery time, and adverse effects related to antibiotic therapy.
Data are analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics are used to summarize demographic and clinical variables. Comparative analyses between groups are performed using appropriate statistical tests, including chi-square tests for categorical variables, with a p-value of less than 0.05 considered statistically significant.
Detailed description
Impacted mandibular third molar extraction is one of the most commonly performed oral surgical procedures and is frequently associated with postoperative complications such as pain, swelling, infection, and alveolar osteitis (dry socket). Antibiotics are commonly prescribed after third molar surgery to reduce the risk of postoperative infections; however, routine systemic antibiotic use may contribute to adverse drug reactions and antibiotic resistance. Topical antibiotic application at the surgical site may offer localized antimicrobial effects while reducing systemic exposure and related complications.
This study is a two-arm, parallel-group randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The study duration is six months from February 2024 to July 2024. Ethical approval was obtained from the Institutional Review Board of Liaquat College of Medicine and Dentistry (REF.No.IRB/D-000090/24), and written informed consent is obtained from all participants before enrollment.
A total of 90 participants aged 18 to 40 years undergoing surgical extraction of impacted mandibular third molars are enrolled and randomly allocated in a 1:1 ratio into two treatment groups using computerized block randomization with allocation concealment through sequentially numbered opaque sealed envelopes. Participants in the experimental group receive topical antibiotic application directly at the extraction site immediately after surgery, while participants in the comparator group receive a standard 5-day postoperative oral antibiotic regimen according to institutional protocol.
All surgical procedures are performed under local anesthesia using standardized surgical techniques by qualified oral surgeons. Follow-up evaluations are conducted on postoperative days 1, 3, 7, and 14 to assess postoperative outcomes.
The primary outcomes include postoperative infection and dry socket incidence. Secondary outcomes include postoperative pain measured using a Visual Analog Scale (VAS), facial swelling, patient satisfaction, recovery time, and adverse effects related to antibiotic therapy.
Data are analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics are used to summarize demographic and clinical variables. Comparative analyses between groups are performed using appropriate statistical tests, including chi-square tests for categorical variables, with a p-value of less than 0.05 considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants undergoing impacted mandibular third molar surgery will be randomly assigned to parallel groups receiving either postoperative oral antibiotics, topical antibiotics, or standard postoperative care/control to compare postoperative outcomes including pain, infection, inflammation, and dry socket incidence.
| Arm | Type | Receives |
|---|---|---|
| Use this module to add descriptions of each arm in the study and to list the interventions being stu | Experimental | Drug: Topical AntibioticParticipants received topical antibiotic application directly at the surgical extraction site immediately after impacted mandibular third molar surgery along with standard postoperative instructions. |
| Oral Antibiotic Group | Active comparator | Drug: Oral antibiotic therapyParticipants received a standard 5-day course of postoperative oral antibiotics following impacted mandibular third molar surgery according to institutional protocol. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Individuals aged 18-40 years.
- Patients scheduled for surgical extraction of impacted mandibular third molars.
- Presence of pain, infection, or impaction requiring extraction.
- Fully or partially impacted mandibular third molars.
- Pell and Gregory Class II or Class III impaction.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Topical AntibioticTopical antibiotic applied locally to the extraction socket immediately after surgical removal of impacted mandibular third molars. | Drug | Use this module to add descriptions of each arm in the study and to list the interventions being stu |
| Oral antibiotic therapyStandard postoperative oral antibiotic regimen administered for 5 days after surgical extraction of impacted mandibular third molars. | Drug | Oral Antibiotic Group |
Primary outcome
Incidence of Postoperative Infection
Time frame: Within 14 days after surgery
Postoperative infection assessed by the presence of clinical signs including redness, swelling, purulent discharge, or fever at the surgical site following impacted mandibular third molar extraction.
Incidence of Dry Socket (Alveolar Osteitis)
Time frame: Postoperative days 3 to 5
Dry socket assessed by severe postoperative pain associated with partial or complete loss of the blood clot at the extraction site after mandibular third molar 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 12 May 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be shared publicly in order to maintain participant confidentiality and comply with institutional ethical guidelines. Aggregated and anonymized study findings will be reported in publications and presentations.
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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 Topical Antibiotic and Oral antibiotic therapy in people with Impacted Tooth and Postoperative Complications in Maxillofacial Surgery, run by Liaquat College of Medicine and Dentistry at 1 site in Pakistan.
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 16 inclusion and 0 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 12 May 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 Pakistan. 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?
Incidence of Postoperative Infection (time frame: Within 14 days after surgery). The study lists 2 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 12 May 2026.