Asepsis During Periodontal Surgery Involving Oral Implants and the Usefulness of Antibiotics: a Prospective, Randomized, Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Rate of post-operative infection
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Rate of post-operative infection
Time Frame: 7 days
signs of infection (fever \> 38 degrees celsius, spontaneous bleeding, pus, swelling, etc.) post-operatively will be checked at suture removal
Secondary Outcomes
No secondary outcomes reported
Investigators
Mahmoud Abu-Ta'a
Associate Professor
Arab American University (Palestine)