Blinder 1999.
| Methods |
Trial design: quasi‐RCT Follow‐up: 7 days |
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| Participants |
Country: Israel Setting: Chaim Sheba Medical Center, Tel Aviv Inclusion criteria: patients on anticoagulant treatment undergoing dental extraction(s) Exclusion criteria: no exclusion criteria were reported Sample size: Control group 1: ‐ Total number of participants: N = 50 ‐ Total number of dental extractions: 119 Control group 2: ‐ Total number of participants: N = 50 ‐ Total number of dental extractions: N = 123 Intervention group (TXA): ‐ Total number of participants: N = 50 ‐ Total number of dental extractions: N = 117 Participant characteristics: ‐ Age mean (range) years: TXA group (group 3): 64 (40 ‐ 93) Control group 1 (group 1): 56 (40 ‐ 86) Control group 2 (group 2): 61 (35 ‐ 79) ‐ Sex N (M/F): 85/65 ‐ INR mean (range) TXA group (group 3): 2.19 (1.50 ‐ 3.58) Control group 1 (group 1): 2.38 (1.50 ‐ 3.60) Control group 2 (group 2): 2.7 (1.9 ‐ 4) |
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| Interventions |
Intervention group: Resorbable gelatin sponge, sutures and TXA mouthwash 500 mg rinsing 2 min 4x daily for a period of 4 days postoperatively, starting 24 hours after the procedure Control groups: Control group 1: resorbable gelatin sponge and sutures Control group 2: resorbable gelatin sponge, sutures and fibrin glue (not eligible for inclusion) |
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| Outcomes | Number of postoperative bleeding episodes requiring intervention Participants were considered to be "bleeding" when haemorrhage manifested one hour postextraction |
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| Notes | Intervention groups eligible for the review: ‐ TXA group: gelatin sponge, sutures and TXA mouthwash ‐ Control group 1: gelatin sponge and sutures (standard care) Intervention group not eligible for the review: ‐ Control group 2: gelatin sponge, sutures and fibrin glue |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "All patients treated on a particular day received the same procedure. The mode of local haemostasis was different for each day, as follows: Day 1. Resorbable gelatin sponge and multiple sutures (silk 000). Day 2. Resorbable gelatin sponge, multiple sutures (silk 000), and mouthwash with tranexamic acid 500mg for 2 min, 4 times daily during a postoperative period of 4 days. Day 3. Fibrin glue, resorbable gelatin sponge, and multiple sutures (silk 000). This order was repeated throughout the study, until there were 50 patients in each group." (Patients and methods, page 138) |
| Allocation concealment (selection bias) | High risk | See citation above |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial is not blinded (see citation above) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial is not blinded (see citation above) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All included participants were analysed |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcome measures are reported for all trial participants |
| Other bias | Unclear risk | It is unclear whether participants could undergo multiple randomisations |