Does clindamycin prevent infection and failure after dental implant placement?

Efficacy of clindamycin in preventing infection and failure after dental implant placement: a placebo-controlled randomized clinical trial. - Efficacy of Clindamycin preventing dental implant failure and infection

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002168-42-ES

Enrollment

Registered

2018-09-17

Start date

2018-12-18

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Healthy volunteers (Postoperative infections and dental implant failures)

Interventions

Trade Name: Clindamicina Qualigen 300 mg cápsulas duras EFG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Clindamycin hydrochloride Other desc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy subjects over the age of 18, without discrimination on the basis of sex or race, who will be given a single implant and who, once informed, will sign a consent form to participate in the trial. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: Pre-randomisation exclusion criteria: patients allergic to amoxicillin, patients who had taken antibiotics for any reason during the 15 days prior to surgery, patients with decompensated systemic pathologies: cardiac, respiratory, endocrine, metabolic, hepatic, haematological, risk of bacterial endocarditis, immunosuppressed, with valvular and orthopedic prostheses in treatment with bisphosphonates, anticoagulants and platelet antiaggregants and those with allergy to any of the drugs used in the trial. Irradiated patients in the cervical-maxillofacial territory. Pregnant women, women suspected of being pregnant or breastfeeding. Patients with a history of antibiotic-associated colitis. Post-randomisation exclusion criteria. At the request of the patient with abandonment of the trial or loss of follow-up.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess wheather a single dose of 600 mg clindamycin hydrochloride (2 hard capsules of 300 mg orally) one hour before surgery is effective, against placebo, in reducing the frequency of failures and infections after the insertion of dental implants.;Secondary Objective: Assess the incidence of adverse effects related to the use of clindamycin hydrochloride;Primary end point(s): Incidence rate of posoperative infection and/or dental implant failure equal to 0%;Timepoint(s) of evaluation of this end point: 8 weeks follow-up after surgery	—

Measure

Time frame

Main Objective: To assess wheather a single dose of 600 mg clindamycin hydrochloride (2 hard capsules of 300 mg orally) one hour before surgery is effective, against placebo, in reducing the frequency of failures and infections after the insertion of dental implants.;Secondary Objective: Assess the incidence of adverse effects related to the use of clindamycin hydrochloride;Primary end point(s): Incidence rate of posoperative infection and/or dental implant failure equal to 0%;Timepoint(s) of evaluation of this end point: 8 weeks follow-up after surgery

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Spain

Contacts

Public ContactUniversity of the Basque Country

Iciar Arteagoitia Calvo

arteagoitia@gmail.com+34946017971

Outcome results

None listed

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