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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska Institutet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

1 Oct 2023 → ongoing

Decision date (initial)

2024-11-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517402-28-00

EudraCT number

2020-004564-26

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

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

Secondary objectives 2

1. Compare quantitative and qualitative changes in the oral and fecal microflora after two different types of antibiotic prophylaxis, short, (single dose Amoxicillin 2 g one hour prior to surgery) versus prolonged prophylaxis (Amoxicillin 2 g one hour prior to surgery + phenoxymethylpenicillin 1,6 g three times daily for seven days after surgery).
2. Assess the development of antibiotic resistance in the oral and fecal microflora after treatment with systemically administered antibiotics.

Conditions and MedDRA coding

Need of Oral bone augmentation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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.

Exclusion criteria 10

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Occurrence of postoperative infection, which will be determined by evaluating the following parameters
2. Pus in surgical field (absolute indication of infection). Defined as discoloured exudate from surgical wound.
3. 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.
4. 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.
5. 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 endpoints 5

1. Survival of augmented material
2. Survival of dental implant (if applicable)
3. Dehiscence of bone augmented area.
4. Quantitative and qualitative change in levels of the oral and faecal microflora.
5. Changes in occurrence of antibiotic resistance in the oral and faecal microflora.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska Institutet

Sponsor organisation

Karolinska Institutet

Address

Alfred Nobels Alle 8, Flemingsberg Flemingsberg

City

Huddinge

Postcode

141 52

Country

Sweden

Scientific contact point

Organisation

Karolinska Institutet

Contact name

Bodil Lund

Public contact point

Organisation

Karolinska Institutet

Contact name

Bodil Lund

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications