The Usefulness of Antibiotics in Smokers Receiving Dental Implants

Arab American University (Palestine)

Status: Completed

Conditions: Dental Implant Therapy

Treatments: Procedure: Antibiotic group; Procedure: Non-Antibiotic group

Study type: Interventional

Funder types: Other

Identifiers

NCT05827211

Antibiotics

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Test group

Experimental group

Description:

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.

Treatment:

Procedure: Antibiotic group

Control group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Non-Antibiotic group