Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall aim of the study is to investigate whether routine administration of antibiotic prophylaxis 1 hour prior to implant surgery may prevent postoperative infection and implant loss in healthy or substantially healthy patients (ASA Class 1 and Class 2).
The prevalence of bacteria resistant to antibiotics is increasing and there is a correlation between high consumption of antibiotics and high incidence of antibiotic resistance. It is therefore important to reduce the prescription of antibiotics. Antibiotics in dental care are used to treat oral infections as well as to prevent infections associated with surgical procedures. An example of the latter is antibiotic prophylaxis associated with dental implant surgery in order to reduce the risk of postoperative infection that can lead to loss of implant.The study will be conducted as a multicenter placebo-controlled randomized clinical trial. Eligible patients will be asked for participation and those who leave oral and written information will be included in the study. Patients included will be allocated to either active treatment (antibiotic prophylaxis) or placebo. Both clinicians and patients will be blinded to group affiliation. A total of 10 clinicians in 8 centers in the south of Sweden have agreed to participate and each clinicians will be allowed to use the implants and routines that they usually work with.
Specific aims of the study are to test the following hypotheses:
If it appears that antibiotic prophylaxis does not lead to any risk reduction, this result may provide a basis for guidelines rejecting antibiotic prophylaxis in dental implant surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin oral tablets | Active Comparator | 2 g amoxicillin tablets orally 1 hour before implant placement |
|
| Placebo | Placebo Comparator | Placebo tablets orally 1 hour before implant placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Antibiotic prophylaxis consisting of 4 amoxicillin tablets, totally 2 g, orally 1 hour before implant placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant failure | Early implant mobility and/or infection, which requires the implant to be removed. | 3-6 months after implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative infection | Presence of swelling, redness, pus, pain and wound dehiscence | 7-14 days after implant placement |
| Infection | Presence of any type of infection such as abscess, fistula |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bengt Götrick | Malmö University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malmö university | Malmö | 20506 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35075765 | Derived | Momand P, Becktor JP, Naimi-Akbar A, Tobin G, Gotrick B. Effect of antibiotic prophylaxis in dental implant surgery: A multicenter placebo-controlled double-blinded randomized clinical trial. Clin Implant Dent Relat Res. 2022 Feb;24(1):116-124. doi: 10.1111/cid.13068. Epub 2022 Jan 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
Not provided
Not provided
Randomized, placebo-controlled trial
Not provided
Not provided
The tablets corresponding to each patient is packed in a container by the manufacturer of the trial drug. Each drug container is labeled by a code number (1-1000) and the contents of the containers are distributed according to a randomization list with block size 6. Randomization is thus carried out by the manufacturer, independent of investigator and participating clinicians.
| Placebo | Other | Placebo consisting of 4 tablets, orally 1 hour before implant placement |
|
|
| 3-6 months after implant placement |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |