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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517402-28-00
Enrollment
80
Registered
2024-11-05
Start date
2023-10-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Need of Oral bone augmentation

Brief summary

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., 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., Pain (relative indication of infection and requires occurrence of one or more of the absolute indications). Subjective report of local pain in surgical field.

Detailed description

Survival of augmented material, 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.

Interventions

DRUGAmimox 500 mg filmdragerade tabletter
DRUGKåvepenin 800 mg filmdragerade tabletter

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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., 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., 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

MeasureTime frame
Survival of augmented material, 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.

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026