Effectiveness of Postoperative Topical and Oral Antibiotics on Impacted Mandibular 3rd Molar Surgery. (POTA-M3S)

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:

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 Overview

• Status: Completed
• Conditions: Surgical Wound Infection; Facial Pain; Impacted Tooth; Postoperative Complications in Maxillofacial Surgery
• Intervention / Treatment: Drug: Topical Antibiotic; Drug: Oral antibiotic therapy

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Liaquat College of Medicine and Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use this module to add descriptions of each arm in the study and to list the interventions being stu; Participants received topical antibiotic application directly at the surgical extraction site immediately after impacted mandibular third molar surgery along with standard postoperative instructions.	Drug: Topical Antibiotic; Topical antibiotic applied locally to the extraction socket immediately after surgical removal of impacted mandibular third molars.
Active Comparator: Oral Antibiotic Group; Participants received a standard 5-day course of postoperative oral antibiotics following impacted mandibular third molar surgery according to institutional protocol.	Drug: Oral antibiotic therapy; Standard postoperative oral antibiotic regimen administered for 5 days after surgical extraction of impacted mandibular third molars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Postoperative days 3 to 5

Collaborators and Investigators

• Sponsor: Liaquat College of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dry Socket; Oral Antibiotics; Topical Antibiotics; Mandibular Third Molar; Postoperative Infection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Tooth Diseases; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Surgical Wound Infection; Tooth, Impacted; Facial Pain; Dry Socket; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 00923002216371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No