USE ANTIBIOTIC OR NOT FOR IMPLANT SURVIVAL

INFLUENCE OF THE ANTIBIOTIC GUIDELINE ON IMPLANT SURVIVAL

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-006142-39-ES

Enrollment

100

Registered

2021-08-13

Start date

2021-08-13

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing implant placement

Interventions

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 Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

—

Secondary

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

Countries

Spain

Contacts

Public ContactUniversidad Complutense de Madrid

Facultad de Odontologia

drcarloscobo@gmail.com3491394 1964

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026