Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening

Study Overview
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Brief Summary
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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 2 g of amoxicillin + clavulanate, or placebo, one hour prior to surgery and without knowing what medicine they took. Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.

Official Title
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Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery

Conditions
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Tooth Wear, Tooth Diseases

Intervention / Treatment
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* Procedure: Surgical crown lengthening
* Drug: Augmentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: in need of surgical crown lengthening operation in one/two teeth Exclusion Criteria: systemic diseases which may affect periodontal tissues and/or healing process such as diabetes mellitus antibiotic or anti-inflammatory drug use in the last 3 months pregnancy/lactation chronic steroid, immunosuppressant or NSAD use age <18 years positive bleeding on probing at the surgical site and/or active periodontal disease <2 mm keratinized mucosa at the surgical site following surgery (estimated surgical outcome before the operation) Miller 2 or 3 tooth mobility penicillin allergy unwilling to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antibiotic prophylaxis<br>per os 2 g augmentin one hour prior to surgery | Procedure: Surgical crown lengthening<br>* Surgical clinical crown lengthening with bone excision<br>Drug: Augmentin<br>* Pre-operative antibiotic prophylaxis (2 g Augmentin)<br>|
| Placebo Comparator: placebo control<br>per os placebo one hour prior to surgery | Procedure: Surgical crown lengthening<br>* Surgical clinical crown lengthening with bone excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |