Skip to main content
. 2018 Jul 2;2018(7):CD012293. doi: 10.1002/14651858.CD012293.pub2

Soares 2015.

Methods Trial design: RCT
Follow up: 7 days
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)
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
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
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
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