Phenoxymethylpenicillin potassium for Need of Oral bone augmentation

Inclusion criteria

• {"criterion_text":"- Male or female ≥18-80 year"}
• {"criterion_text":"- Partially or completely edentulous subjects with healthy or treated periodontal conditions."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Inadequate amount of bone to allow insertion of dental implant according to the operating surgeon."}
• {"criterion_text":"- Signed informed consent."}

Exclusion criteria

• {"criterion_text":"- Known allergy to amoxicillin, phenoxymethylpenicillin or other betalactam antibiotic."}
• {"criterion_text":"- Current participation in other medical study."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Incapability to perform basal oral hygiene measures due to physical or mental disorders."}
• {"criterion_text":"- Received systemic antimicrobial therapy in the past three months."}
• {"criterion_text":"- Currently on allopurinol, probenicid, methotrexate, or warfarin."}
• {"criterion_text":"- Untreated periodontal condition."}
• {"criterion_text":"- Active smoking."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Occurrence of postoperative infection, which will be determined by evaluating the following parameters","definition_or_measurement_approach":"Determined by evaluating the following parameters: pus in surgical field (absolute indication of infection; defined as discoloured exudate from surgical wound), occurrence 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), swelling 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), and pain (relative indication of infection and requires occurrence of one or more of the absolute indications; subjective report of local pain in surgical field)."}
• {"endpoint_text":"- Pus in surgical field (absolute indication of infection). Defined as discoloured exudate from surgical wound.","definition_or_measurement_approach":"Defined as discoloured exudate from surgical wound; considered an absolute indication of infection."}
• {"endpoint_text":"- Occurrence 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.","definition_or_measurement_approach":"Defined as communication between oral cavity and implanted material confirmed by using a gingival pocket probe; considered an absolute indication of infection."}
• {"endpoint_text":"- Swelling 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.","definition_or_measurement_approach":"Defined as objective pathologic increase in tissue volume over surgical field compared to contralateral side or normal condition; considered a relative indication and requires one or more absolute indications to diagnose infection."}
• {"endpoint_text":"- Pain (relative indication of infection and requires occurrence of one or more of the absolute indications). Subjective report of local pain in surgical field.","definition_or_measurement_approach":"Subjective report of local pain in the surgical field; considered a relative indication and requires one or more absolute indications to diagnose infection."}

Secondary endpoints

• {"endpoint_text":"- Survival of augmented material","definition_or_measurement_approach":""}
• {"endpoint_text":"- Survival of dental implant (if applicable)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Dehiscence of bone augmented area.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quantitative and qualitative change in levels of the oral and faecal microflora.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in occurrence of antibiotic resistance in the oral and faecal microflora.","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

292

Number Of Sites

2

Number Of Participants

80

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden