The effect of oral antibiotics on clinical and patient-centered outcomes of implant therapy and simultaneous guided bone regeneration. A randomised controlled clinical trial.
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
- Registration Number
- EUCTR2013-001811-56-AT
- Lead Sponsor
- Medizinische Universität Graz, Universitätsklinik für Zahn-, Mund- und Kieferheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Healthy people (ASA I-II) with a minimum age of 21, preferably non-smokers, no allergy against Amoxicillin or Penicillin, bone loss at class 1-3 (Schincaglia and Nowzari)
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 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56
Medical compromised person (ASA III-V), general contraindications against implants, therapies which influence the bone and soft tissue regeneration, smokers, allergics against amoxicillin or penicillin, antibiotics taken in the last 3 months or patients with antibiotics prohylaxe, pregnancy or pregnancy in planning or nurseing, tooth gaps with b-l bone-dimensions<3mm, m-d dimensions<7mm and <8mm high, patients under 21,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: There are no clinical advantages of a prae- and post-operation antibiotics therapy.;Secondary Objective: To determine the effect of systemic antibiotic prophylaxis on patient-centred outcomes and perception following oral implant therapy and guided bone regeneration.;Primary end point(s): For the test group, the risk involved would be the development of antibiotic resistance and known side-effects of the drug used, like diarrhoea. As for the control group, there may be an increased risk of infection and post-operative complications following the procedure, and possible increased risk of early implant loss
- Secondary Outcome Measures
Name Time Method