Soares 2015.
Methods |
Trial design: RCT Follow up: 7 days |
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Participants |
Country: Brazil Setting: single centre, Federal University of Ceará Inclusion criteria: ‐ People using warfarin ‐ Requiring extractions of at least 2 teeth ‐ Minimum age of 18 years Exclusion criteria: ‐ Use of associated anticoagulating medications (other than warfarin) ‐ Smokers, pregnant or lactating women ‐ Reported pre‐existing blood dyscrasias ‐ Individuals who did not return for reassessment were removed from the trial ‐ Surgical sites subjected to procedures requiring mucoperiosteal flap for dental extractions or that lasted longer than 30 min were not included in the study sample Sample size: TXA group: ‐ Total number of surgical procedures: 28 ‐ Total number of participants: 12 Fibrin sponge group: ‐ Total number of surgical procedures: 28 ‐ Total number of participants: 13 Control group (dry gauze): ‐ Total number of surgical procedures: 28 ‐ Total number of participants: 13 Number of individuals analysed/randomised: ‐ Total number of surgical procedures analysed/randomised: 84/93 ‐ TXA group: 28/33 ‐ Fibrin sponge group: 28/32 ‐ Control group (dry gauze): 28/28 Participant characteristics: ‐ Age in years (mean (SD)) TXA group: 51.0 (2.9); fibrin sponge group: 51.1 (3.3); control group (dry gauze): 51.1 (2.8) ‐ Sex (M/F): N = 22/16 ‐ Mean (SD) INR: TXA group: 2.52 (0.16); fibrin sponge group: 2.51 (0.16); control group (dry gauze): 2.51 (0.13) |
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Interventions |
Intervention group 1: Gauze pad soaked in 4.8% TXA was applied to the surgical alveolus for 8 min under biting pressure Intervention group 2: Fibrin sponge was packed into the surgical alveolus, and the individual was asked to bite down on the gauze for 8 min for compression Control group: Dry gauze compression was performed under biting pressure on the surgical alveolus for 8 min without the use of local haemostatic agents All groups: Surgical sites were occluded with suture in "X" fashion (silk 4.0) Only 1 tooth was extracted per appointment |
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Outcomes | Number of postoperative bleeding episodes requiring intervention Postoperative bleeding was defined as bleeding on the extraction site that could not be controlled by gauze compression during 20 min and/or requiring medical intervention |
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Notes | Intervention and control groups eligible for the review: ‐ Intervention group 1: gauze pad soaked in 4.8% TXA ‐ Control group: dry gauze compression Intervention groups not eligible for the review: ‐ Intervention group 2: fibrin sponge |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Extraction sites were considered as sampling units and, according to the local haemostatic procedure to be performed, were randomly allocated into one of the three study groups by using a computer‐generated code:…" (Patients and methods, page 210) |
Allocation concealment (selection bias) | Unclear risk | There is no indication of adequate allocation concealment in the text |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The performance of the interventions was not blinded (Patients and methods, page 211) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The investigator who contacted the study participants for the purpose of evaluating bleeding complications was blinded to the haemostatic protocol allocation throughout the study period” (Patients and methods, page 212) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up of three participants (N = 9 surgical procedures), however the percentage of participants that were lost to follow‐up was less than 10% |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcome measures are reported for all trial participants |
Other bias | High risk | Participants were randomised more than once. Considered as high risk of bias, as participants were not blinded |
INR: international normalised ratio RCT: randomised controlled trial SD: standard deviation TXA: tranexamic acid