The effect of oral antibiotics on clinical and patient-centered outcomes of implant therapy and simultaneous guided bone regeneration. A randomised controlled clinical trial.

The effect of systemic antibiotics on clinical and patient-centered outcomes of implant therapy and simultaneous guided bone regeneration. A randomised controlled clinical trial. - Syst. Antibiotics & GBR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001811-56-AT

Enrollment

Unknown

Registered

2014-09-01

Start date

2014-09-26

Completion date

Unknown

Last updated

2018-06-11

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

Conditions

None listed

Interventions

Trade Name: Amoxilan Product Code: ATC-Code: J01CA04 Pharmaceutical Form: Capsule, hard INN or Proposed INN: AMOXICILLIN CAS Number: 26787-78-0 Current Sponsor code: Internationale Apotheke Wien Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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,

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Australia, Austria, China, Hong Kong, Iceland, Singapore

Contacts

Public ContactDept. of Oral Surgery & Radiology

PD. DDr. Michael Payer

mi.payer@medunigraz.at4331638580659

Outcome results