Effectiveness of Postoperative Topical and Oral Antibiotics on Impacted Mandibular 3rd Molar Surgery.

NCT07573033 | Completed Phase 4

• 1 other identifier: 00923002216371
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Impacted Mandibular Third Molar Postoperative Surgical Site Infection Postoperative Pain Postoperative Inflammation Dry Socket (Alveolar Osteitis)

Keywords

Dry Socket; Mandibular Third Molar; Oral Antibiotics; Postoperative Infection; Topical Antibiotics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Drug: Oral antibiotic therapy

Interventions

Topical Antibiotic DRUG

Topical antibiotic applied locally to the extraction socket immediately after surgical removal of impacted mandibular third molars.

Use this module to add descriptions of each arm in the study and to list the interventions being stu

Oral antibiotic therapy DRUG

Standard postoperative oral antibiotic regimen administered for 5 days after surgical extraction of impacted mandibular third molars.

Oral Antibiotic Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged 18 to 40 years undergoing surgical extraction of impacted mandibular third molars Presence of fully or partially impacted mandibular third molars classified as Pell and Gregory Class II or III Patients requiring extraction due to pain, infection, impaction, or related clinical indications Medically fit for oral surgical procedures and antibiotic therapy Willingness to provide written informed consent and comply with follow-up visits

You may not qualify if:

• Known allergy or hypersensitivity to antibiotics or local anesthetic agents
• History of previous surgery in the same anatomical area
• Presence of active oral infections or poor oral hygiene
• Systemic diseases contraindicating surgery or antibiotic use
• Pregnant or breastfeeding women
• Inability or unwillingness to attend follow-up visits
• Use of antibiotics shortly before surgery that may affect study outcomes

Sponsors & Collaborators

• Liaquat College of Medicine and Dentistry: lead

Study Sites (1)

Liaquat College of Medicine and Dentistry

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Dry Socket

Interventions

Anti-Bacterial Agents; Anti-Infective Agents

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, participants and operating surgeons could not be blinded. However, the outcome assessor and data analyst were blinded to treatment allocation to minimize assessment and analytical bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: February 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)