Antibiotic prophylaxis protocol to prevent postoperative complications in uncontrolled diabetic patients undergoing simple teeth extractions: A randomized, double-blind, single-center trial
- Conditions
- Oral Health
- Registration Number
- PACTR202101511724343
- Lead Sponsor
- Research Laboratory LR 12SP10 Functional and Aesthetic Rehabilitation of Maxillary
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 180
Male or female patients
18 years or older
Patients with known history of insulin-dependent diabetes or noninsulin-dependent diabetes mellitus with glycosylated hemoglobin levels between 8% and 11% the previous two to three months.
Extraction requiring minimal instrumentations.
Surgical extraction procedure
Immuno compromised patients or patient having diseases or conditions associated with impaired wound or osseous healing like: HIV,AIDS,hematologicalneoplasia, following transplant surgery,patient undergoing chemotherapy,patient under or with antecedents of antiresorptive drugs administration (bisphosphonate, denosumab),patient undergoing or with history of radiation in the maxillafacial region,patient under immunosupressive drugs: corticosteroids, thalidomide
Patients undergoing extractions of endodontically treated teeth
Patient currently taking antibiotics at the time of extraction or have had
antibiotics less than 3days prior to extraction
Patient with habits wich are known to be determinal to oral wound
healing such as smoking, alcohool…
Co-existing of local or systemic infection
Pregnant and lacting patients
Recent use of any anti-inflammatory drugs (used within one month previous)
Allergy to drugs used in the study
Patients taking antibiotics within 1 week after extraction for other infectious diseases.
Having a dental emergency
Having acute dental or periodontal infections requiring antibiotic prescription
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of postoperative complication including:<br>Dry socket: persistent pain and exposure of the alveolar bone.<br>Suppurated alveolitis: which identified by provoked pain and alveolus filled; the clot becomes infected, covered by a grayish green membrane and it may consists of dental fragments or osseous sequestrum.<br>Abscess: Localized bacterial infection, localized pain and swelling, it may present clinically as a fluctuant buccal or palatal swelling, with or without a draining fistula.<br>Cellulitis: may follow tooth extraction if the infection spreads into the surrounding tissues. Diffuse, tense, painful swelling of the affected tissues occurs. Regional lymphadenopathy is common, and fever may be present.
- Secondary Outcome Measures
Name Time Method Delayed wound healing:<br>According to the literature, the dental alveolus is filled with blood clot and fibrin at 3 days after dental extraction; on postoperative day 7, the alveolus is filled with granulation tissue; on postoperative day 21, wound epithelialization is complete; and on postoperative day 60, alveolar bone formation can be observed on a dental radiographic image. Delayed wound healing was defined as a delay in any of the aforementioned events