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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral and Maxillofacial Surgery department in Subbaiah Institute of Dental Sciences

Shimoga, Karnataka, 577201, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Assessment of the extraction socket healing of both the groups using a modified Landry's Wound Healing Index

Time frame: postoperative 5th day
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

Sponsors and collaborators

Lead sponsor

Subbaiah Institute of Dental Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 10, 2026
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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