Oral Hemorrhage
Conditions
Interventions
This is a clinical study that will be carried out in a randomized, controlled, split-mouth fashion, where the research participant is both control and experiment at the same time, and the unit of rand
E02.520.490
Sponsors
Programa de Pós-Graduação em odontologia da Universidade Federal Fluminense
Universidade Federal Fluminense
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: The physical criteria included research participants with bilateral third molars indicated for extraction; aged between 18 and 40 at the time of recruitment; both genders; the psychological criteria for participation in the project comprised patients with no history of anxiety; mood; eating; or psychotic disorders that could compromise their participation and collaboration in the study; these were evaluated by completing an anamnesis form
Exclusion criteria
Exclusion criteria: All research participants who smoked; were dependent on alcohol; had systemic diseases (eg, diabetes, blood dyscrasias) were excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome expected 1: The experimental Hemospon sponge is expected to promote equal or better bleeding control compared to the control Gelfoam sponge in managing bleeding in the sockets of lower third molars after extractions and filling the sockets with these hemostatic sponges. Evaluation of bleeding control in lower third molar socket after extractions and filling of the alveoli with two different hemostatic sponges (control and experimental). Bleeding will be analyzed 30 and 60 minutes after the end of the alveolar suture. Bleeding will be assessed using scores ranging from 0-3, where 0: No bleeding within 30 seconds of probing; 1: bleeding within a few seconds of probing; 2: Immediate bleeding on probing; and 3: Bleeding along the gingival sulcus at the slightest touch, according to Muhlemann's classification;Primary outcome found 1: At 30 minutes, the Hemospon® group shows a higher number of participants with scores 1 and 2, while the Surgifoam® group has most participants with a score of 0. A similar pattern is observed at 60 minutes, with Hemospon® showing more participants with scores 1 and 2, and most participants in the Surgifoam® group retaining a score of 0. Fisher’s exact test revealed no statistically significant differences between the groups, with p-values of 0.3157 and 0.7688 for 30 minutes and 60 minutes, respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome expected 2: Pain will be analyzed using the Visual Analogue Scale (VAS), with 0 being no pain and 10 being the most severe pain, along with a graphic rating scale. The number of analgesics consumed will also be recorded after 1 and 2 weeks of the surgeries. ;Secondary outcome expected 3: Soft tissue healing will be assessed using scores 0-3, according to the Brancacio scale: 0 = complete closure without fibrin - 1 = complete closure with fibrin - 2 = incomplete closure of the socket (dehiscence) - 3 = incomplete closure with signs of necrosis. This assessment will be carried out 1 and 2 weeks after extractions;Secondary outcome found 2: Postoperative pain evaluation using the Visual Analog Scale (VAS) at 1, 2, 3, and 7 days after tooth extractions: no significant differences were observed between groups within the same experimental periods (p>0.05);Secondary outcome found 3: Soft tissue healing assessment at 7 and 14 days using the Brancaccio scale (scores 0–3): Fisher’s exact test confirmed no significant differences were observed between the Hemospon (test) and Surgifoam (control) groups at 7 days (p=0.200) and 14 days (p=0.730) | — |
Countries
Brazil
Contacts
Public ContactMonica Calasans Maia
Maquira Industria de Produtos Odontológicos SA
Outcome results
None listed