Role of antibiotics in connection with oral bone transplantation.

Phase 1

• Conditions: Patients requiring bone augmentation procedure prior to, or in conjunction to installation of dental implants.; MedDRA version: 20.0Level: PTClassification code 10049924Term: Infection prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2020-004564-26-SE
• Lead Sponsor: Karolinska Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

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.

Study & Design

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