The Usefulness of Antibiotics in Smokers Receiving Dental Implants

Study Overview
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Brief Summary
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Objectives: This randomized clinical trial will compare the usefulness of pre- and postoperative antibiotics while strict asepsis will be followed during periodontal surgery in smokers diagnosed with Stage III Grade C Generalized Periodontitis. Material and Methods: Two groups of 40 consecutive patients each with fully or partially edentulous jaws will be enrolled. Antibiotics group (GrAB+): will receive oral doxycycline 200 mg, 1 h pre-operatively and 100 mg g for 9 days post-operatively. Non-antibiotics group (GrAB- ): will receive a placebo (no antibiotics). Bacterial samples will be taken from the peri-oral skin before and at the end of the surgery. In 12 patients in each group, samples will also be taken from the nares. A visual analogue scale will evaluate symptoms of infection/ inflammation by both the patient and the periodontist at suture removal.

Official Title
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Asepsis During Periodontal Surgery Involving Oral Implants and the Usefulness of Antibiotics: a Prospective, Randomized, Controlled Clinical Trial

Conditions
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Dental Implant Therapy

Intervention / Treatment
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* Procedure: Antibiotic group
* Procedure: Non-Antibiotic group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoker in need of dental implant therapy above 18 years of age Exclusion Criteria: allergy to doxycycline, need for endocarditis prophylaxis, any systemic or local immunodeficiency, uncontrolled diabetes mellitus, previous radiation therapy in the head and neck area

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Participants in this group will receive Doxycycline 200 mg 1 h pre-op and 100 mg for 9 days post-op in combination with dental implant therapy. | Procedure: Antibiotic group<br>* Partially or fully edentulous smoker patients will be treated by dental implants and will receive systemic antibiotics<br>* Other names: Dental implant insertion + Antibiotics;|
| Placebo Comparator: Control group<br>Participants in this group will receive a placebo 200 mg 1 h pre-op and 100 mg for 9 days post-op in combination with dental implant therapy. | Procedure: Non-Antibiotic group<br>* Partially or fully edentulous smoker patients will be treated by dental implants and will receive placebo<br>* Other names: Dental implant insertion + Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of post-operative infection | signs of infection (fever > 38 degrees celsius, spontaneous bleeding, pus, swelling, etc.) post-operatively will be checked at suture removal | 7 days |