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The goal of this clinical trial is to test the effects of prophylactic antibiotics in healthy individuals who are in need of surgical crown lengthening. The main question it aims to answer is if single dose antibiotics prior to surgical crown lengthening has any effects on the healing outcomes.
Participants will be asked to take either
Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antibiotic prophylaxis | Experimental | per os 2 g augmentin one hour prior to surgery |
|
| placebo control | Placebo Comparator | per os placebo one hour prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical crown lengthening | Procedure | Surgical clinical crown lengthening with bone excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early healing index (inflammation phase) | Scores are given as specified below (Hamzani et al. 2018) Bleeding (spontaneous or provoked) Yes: 0; No: 1 Granulation tissue Yes: 0; No: 1 Hematoma Yes: 0; No: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Incision margins Incomplete flap closure/fibrin clot/partial or complete necrosis: 0; Complete closure/fine fibrin line: 1 Suppuration Yes: 0; No: 1 Edema VAS 6-10: 0; VAS 1-5: 1 Pain VAS 6-10: 0; VAS 1-5: 1 | at 3 days |
| Early healing index (proliferation phase) | Scores are given as specified below (Hamzani et al. 2018) Re-epithelization Partial: 0; Complete: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Suppuration Yes: 0; No: 1 Pain VAS 6-10: 0; VAS 1-5: 1 | at 10 days |
| Early healing index (remodeling phase) | Scores are given as specified below (Hamzani et al. 2018) Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Pain VAS 6-10: 0; VAS 1-5: 1 | at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustafa YILMAZ, PhD, DDS | Contact | +902124440276 | myilmaz@biruni.edu.tr | |
| Ayse Ege Selman, DDS | Contact | +902124440276 | aselman@biruni.edu.tr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30324746 | Background | Hamzani Y, Chaushu G. Evaluation of early wound healing scales/indexes in oral surgery: A literature review. Clin Implant Dent Relat Res. 2018 Dec;20(6):1030-1035. doi: 10.1111/cid.12680. Epub 2018 Oct 15. |
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| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D057085 | Tooth Wear |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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| Augmentin | Drug | Pre-operative antibiotic prophylaxis (2 g Augmentin) |
|
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |