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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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:
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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suchith S Shetty, Masters in Dental Surgery | Subbaiah Institute of Dental Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral and Maxillofacial Surgery department in Subbaiah Institute of Dental Sciences | Shimoga | Karnataka | 577201 | India |
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| ID | Term |
|---|---|
| D010482 | Periapical Abscess |
| ID | Term |
|---|---|
| D000038 | Abscess |
| D013492 | Suppuration |
| D007239 | Infections |
| D010485 | Periapical Periodontitis |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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It is a triple-blinded, parallel-group, randomized controlled clinical trial
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|
| D010483 |
| Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |