"Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Teeth With Abscess?"

"Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Tooth With a Periapical Abscess? : A Randomised Controlled Clinical Study"

This is a triple-blind randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Subbaiah Institute of Dental Sciences, Shimoga. The study enrolls 176 adult patients aged above 18 years belonging to ASA class 1 or 2, requiring intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess of less than 1.5 cm in diameter. Patients are randomly allocated into two equal groups of 88 each. Group A receives postoperative Amoxicillin 500 mg thrice daily for 5 days in addition to standard analgesics. Group B receives only standard analgesics with no antibiotic prescription. The primary outcome measure is wound healing assessed on postoperative day 5 using a modified Landry Wound Healing Index evaluating gingival tissue color, response to palpation, presence of granulation tissue, and suppuration.

Study Overview

• Status: Completed
• Conditions: Periapical Abscess
• Intervention / Treatment: Drug: Amoxicillin 500mg

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Shimoga, Karnataka, India, 577201
      • Oral and Maxillofacial Surgery department in Subbaiah Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients aged above 18 years
• Patients who are willing to participate in the study
• Patients requiring extraction of non-restorable carious teeth with radiographic evidence of periapical abscess (< 1.5cm diameter ill-defined, diffused periapical radiolucent lesion )
• Patients who come under ASA class 1 and 2 classification

Exclusion Criteria:

• Patients requiring trans-alveolar extraction
• Patients with known Penicillin allergy
• Pregnant women
• Patients undergoing antibiotic therapy perioperatively
• Patients not complying with follow-up

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1(Group A): Extraction with postoperative antibiotics (Capsule Amoxicillin 500mg TID for 5 days); 88 patients undergoing intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess receiving postoperative Amoxicillin 500 mg thrice daily after food for 5 days along with standard analgesics. Wound healing is assessed on the 5th postoperative day using a modified Landry Wound Healing Index.	Drug: Amoxicillin 500mg; A single operator performs intra-alveolar extraction under local anaesthesia using 2 per cent Lignocaine with Adrenaline 1 in 200000. The procedure involves detachment of gingival mucoperiosteum without incisions, forceps or elevator extraction without ostectomy, saline irrigation, manual compression of socket and placement of moist gauze pack for pressure. Postoperatively, Amoxicillin 500 mg is administered to patients in Group A, thrice daily after food for 5 days. Standard postoperative instructions are provided and patient is reviewed on the 5th postoperative day
No Intervention: Arm 2 (Group B): Extraction without postoperative antibiotics; 88 patients undergoing intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess receiving only standard analgesics postoperatively with no antibiotic prescription. Wound healing is assessed on the 5th postoperative day using a modified Landry Wound Healing Index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the extraction socket healing of both the groups using a modified Landry's Wound Healing Index	On postoperative day 5, a blinded investigator assesses the socket using a modified Landry's Wound Healing Index. The primary outcomes include: Gingival Tissue Colour: Rated from "more than 50% red" to "all pink".; Response to Palpation: Presence or absence of bleeding.; Granulation Tissue: Presence or absence.; Suppuration: Presence or absence. Scores are assigned from 1 (Very Poor) to 5 (Excellent) based on these criteria. If a patient experiences pain before the follow-up, they are examined for dry socket and managed accordingly	postoperative 5th day

Collaborators and Investigators

• Sponsor: Subbaiah Institute of Dental Sciences
• Investigators: Principal Investigator: Suchith S Shetty, Masters in Dental Surgery, Subbaiah Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Actual): September 5, 2025
• Study Completion (Actual): September 10, 2025

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Antibiotics; Randomized Controlled Trial; Wound Healing; Tooth Extraction; Antibiotic Resistance; Periapical Abscess
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Infections; Suppuration; Abscess; Periodontitis; Periapical Periodontitis; Periapical Abscess; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; Penicillin G; beta-Lactams; Lactams; Ampicillin; Penicillins; Amoxicillin
• Other Study ID Numbers: IEC Ref. No. SIDS/IEC/0127

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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