Does clindamycin prevent infection and failure after dental implant placement?

Phase 1

• Conditions: Healthy volunteers (Postoperative infections and dental implant failures); Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2017-002168-42-ES
• Lead Sponsor: Iciar Arteagoitia Calvo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 62

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable