Periapical Abscess
Conditions
Keywords
Antibiotics, Periapical Abscess, Tooth Extraction, Wound Healing, Antibiotic Resistance, Randomized Controlled Trial
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.
Interventions
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
Sponsors
Subbaiah Institute of Dental Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
It is a triple-blinded, parallel-group, randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the extraction socket healing of both the groups using a modified Landry's Wound Healing Index | 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 |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORSuchith S Shetty, Masters in Dental Surgery
Subbaiah Institute of Dental Sciences
Outcome results
None listed