Patients requiring bone augmentation procedure prior to, or in conjunction to installation of dental implants. MedDRA version: 20.0 Level: PT Classification code 10049924 Term: Infection prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Kåvepenin
Product Name: Kåvepenin
Pharmaceutical Form: Tablet
Sponsors
Karolinska Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female =18-80 year 2. Partially or completely edentulous subjects with healthy or treated periodontal conditions. 3. Patients who have been referred by a general dentist or specialist in prosthodontics to a specialist clinic in oral and maxillofacial surgery, for treatment with dental implants. 4. Inadequate amount of bone to allow insertion of dental implant according to the operating surgeon. 5. Signed 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Known allergy to amoxicillin, phenoxymethylpenicillin or other betalactam antibiotic. 2. Contraindication for dental surgical treatment (i.e. immunocompromised, uncontrolled DM (B-GHb-A1C 8–9 %, 64– 75 mmol/ml), osteoporosis, i.v. bisphosphonate treatment due to malignancy, pregnant and lactating women). 3. Incapability to perform basal oral hygiene measures due to physical or mental disorders. 4. Received systemic antimicrobial therapy in the past three months. 5. Currently on allopurinol, probenicid, methotrexate or warfarin. 6. Untreated periodontal condition. 7. Active smoking. 8. Any medical condition or on any concomitant medication that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or jeopardize subjects’ safety. 9. Patients with xerostomia or having slow bowel motion (less than one stool daily) will be excluded from the group of subjects providing salivary and fecal samples. 10. Current participation in other medical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of short or prolonged antibiotic prophylaxis respectively, on occurence of postoperative infections after bone augmentation procedures in conjunction with, or prior to, dental implant treatment.;Secondary Objective: To evaluate impact on and recovery time for the normal oral and intestinal microflora after a single dose antimicrobial prophylaxis and prolonged prophylaxis, respectively.;Primary end point(s): Occurrence of postoperative infection, which will be determined by evaluating the following parameters oPus in surgical field (absolute indication of infection). Defined as discoloured exudate from surgical wound. oOccurrence of fistula in surgical field (absolute indication of infection). Defined as communication between oral cavity and implanted material through confirmed by using gingival pocket probe. oSwelling in surgical field (relative indication of infection and requires occurrence of one or more of the absolute indications). Defined as objective pathologic increase in tissue volume over surgical field compared to contralateral side or normal condition. oPain (relative indication of infection and requires occurrence of one or more of the absolute indications). Subjective report of local pain in surgical field. ;Timepoint(s) of evaluation of this end point: At visit 3 (day 14) Visit 4, 3 months after surgery Visit 5, 6 months after surgery Visit 6, 12 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Survival of augmented material and dental implants • Survival of dental implant (if applicable) • Dehiscence of bone augmented area. • Quantitative and qualitative change in levels of the oral and faecal microflora. • Changes in occurrence of antibiotic resistance in the oral and faecal microflora. ;Timepoint(s) of evaluation of this end point: At visit 3 (day 14) Visit 4, 3 months after surgery Visit 5, 6 months after surgery Visit 6, 12 months after surgery | — |
Countries
Sweden
Contacts
Public ContactBodil Lund
Karolinska Institute
Outcome results
None listed