SE ANTIBIOTIC OR NOT FOR IMPLANT SURVIVA

Phase 1

• Conditions: Patients undergoing implant placement; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2020-006142-39-ES
• Lead Sponsor: Facultad de Odontología. Universidad Complutense de Madrid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-13
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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

Exclusion 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 with severe systemic diseases, immunosuppressed or using inhalers.
•Pregnant women.
• Patients allergic to penicillin.
• Patients with tobacco consumption.
• Patients with lactose intolerance.
• Implants that require an added procedure that may alter the perception and possible complications of the treatment (bone regeneration with membrane and bone).
• Previous tumors in the area.
• Patients with inadequate initial radiographs for analysis.
• Patients with improperly completed data collection sheets.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Finish at 5th month;Timepoint(s) of evaluation of this end point: 5 months;Main Objective: Determine the influence of antibiotic treatment on the appearance of infection after the placement of dental implants.;Secondary Objective: Compare the survival percentage of the implants based on prescribing oral antibiotic treatment or a placebo.<br>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.<br>Register and compare the appearance of complications in the postoperative period of implant placement in patients treated with antibiotic versus placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Periodic visits of patients;Timepoint(s) of evaluation of this end point: 1 week, 1 month, 3 months, 5 months