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

NCT07694531 | Completed

• 1 other identifier: IEC Ref. No. SIDS/IEC/0127
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periapical Abscess

Keywords

Antibiotics; Periapical Abscess; Tooth Extraction; Wound Healing; Antibiotic Resistance; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm 1(Group A): Extraction with postoperative antibiotics (Capsule Amoxicillin 500mg TID for 5 days)

EXPERIMENTAL

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

Arm 2 (Group B): Extraction without postoperative antibiotics

NO INTERVENTION

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.

Interventions

Amoxicillin 500mg DRUG

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

Arm 1(Group A): Extraction with postoperative antibiotics (Capsule Amoxicillin 500mg TID for 5 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Subbaiah Institute of Dental Sciences: lead

Study Sites (1)

Oral and Maxillofacial Surgery department in Subbaiah Institute of Dental Sciences

Shimoga, Karnataka, 577201, India

Location

MeSH Terms

Conditions

Periapical Abscess

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections; Periapical Periodontitis; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Suchith S Shetty, Masters in Dental Surgery

  Subbaiah Institute of Dental Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It is a triple-blinded, parallel-group, randomized controlled clinical trial

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 10, 2026
• Study Start: March 20, 2025
• Primary Completion: September 5, 2025
• Study Completion: September 10, 2025
• Last Updated: July 10, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)