INFLUENCE OF THE ANTIBIOTIC GUIDELINE ON IMPLANT SURVIVAL

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2021
INTERVENTION: Trade Name: Amoxicillin Product Name: Amoxicillin Pharmaceutical Form: Pastille INN or Proposed INN: AMOXICILLIN CAS Number: 26787‐78‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 750‐ Pharmaceutical form of the placebo: Pastille Route of administration of the placebo: Oral use CONDITION: Patients undergoing implant placement Therapeutic area: Health Care [N] ‐ Environment and Public Health [N06] PRIMARY OUTCOME: Main Objective: Determine the influence of antibiotic treatment on the appearance of infection after the placement of dental implants. Primary end point(s): Finish at 5th month Secondary Objective: Compare the survival percentage of the implants based on prescribing oral antibiotic treatment or a placebo.; Compare the marginal bone loss between the group of implants with antibiotic treatment versus implants with placebo at 7 days, 1 month, 3 months and 5 months.; Register and compare the appearance of complications in the postoperative period of implant placement in patients treated with antibiotic versus placebo. Timepoint(s) of evaluation of this end point: 5 months SECONDARY OUTCOME: Secondary end point(s): Periodic visits of patients Timepoint(s) of evaluation of this end point: 1 week, 1 month, 3 months, 5 months INCLUSION CRITERIA: • Patients between 18 and 85 years old. • Health status (ASA I and II). • Patients with indication of 1 to 3 implants for fixed prostheses on implants. • Patients who demonstrate understanding of the study and willingness to participate and sign the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 9cdb6daae5fcc46503aced6ddb04a7bbe091a6d8
First added on: Aug 25, 2024