Role of antibiotics in conjunction with oral bone augmentation procedures (BAS20)

Phase 2

Recruiting

• Conditions: Need of Oral bone augmentation

• Registration Number: 2024-517402-28-00
• Lead Sponsor: Karolinska Institutet

Brief Summary

The primary objective is to evaluate the efficacy of short versus prolonged antibiotic prophylaxis in conjunction to bone augmentation procedures in dental implant surgery.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Male or female ≥18-80 year

Partially or completely edentulous subjects with healthy or treated periodontal conditions.

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.

Inadequate amount of bone to allow insertion of dental implant according to the operating surgeon.

Signed informed consent.

Exclusion Criteria

Known allergy to amoxicillin, phenoxymethylpenicillin or other betalactam antibiotic.

Current participation in other medical study.

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).

Incapability to perform basal oral hygiene measures due to physical or mental disorders.

Received systemic antimicrobial therapy in the past three months.

Currently on allopurinol, probenicid, methotrexate, or warfarin.

Untreated periodontal condition.

Active smoking.

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.

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Occurrence of postoperative infection, which will be determined by evaluating the following parameters		Occurrence of postoperative infection, which will be determined by evaluating the following parameters
Pus in surgical field (absolute indication of infection). Defined as discoloured exudate from surgical wound.		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.		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.		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.
Pain (relative indication of infection and requires occurrence of one or more of the absolute indications). Subjective report of local pain in surgical field.		Pain (relative indication of infection and requires occurrence of one or more of the absolute indications). Subjective report of local pain in surgical field.

Secondary Outcome Measures

Name	Time	Method
Survival of augmented material		Survival of augmented material
Survival of dental implant (if applicable)		Survival of dental implant (if applicable)
Dehiscence of bone augmented area.		Dehiscence of bone augmented area.
Quantitative and qualitative change in levels of the oral and faecal microflora.		Quantitative and qualitative change in levels of the oral and faecal microflora.
Changes in occurrence of antibiotic resistance in the oral and faecal microflora.		Changes in occurrence of antibiotic resistance in the oral and faecal microflora.

Trial Locations

Locations (1)

Jönköping Regional Hospital; 🇸🇪 Jönköping, Sweden

Jönköping Regional Hospital

🇸🇪Jönköping, Sweden

Fredrik Holmqvist

Site contact

+46102426056

fredrik.holmqvist@rjl.se