five

CONSORT check list

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DataCite Commons2022-06-11 更新2024-08-18 收录
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https://figshare.com/articles/dataset/CONSORT_check_list/20055599
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This was a multicentric, prospective, two-arm, parallel-group, randomized (1:1), single-blind study, conducted in two different centers between July 2020 and November 2021. The primary objective of the study was to compare tissue reaction/ inflammation with Trusilk® and Mersilk® silk sutures post primary closure of mucosa in subjects undergoing planned surgical removal of impacted mandibular third molar at 3 and 7 days. The secondary objectives were to compare the incidence of tissue reaction and infection, the effect of suture material on wound healing and other surgical outcomes, overall intraoperative handling, and the common post-surgical complications between the two groups, Trusilk® and Mersilk®. Post-screening (screening visit), the study participants underwent surgical procedures (baseline visit, Day 0). All routine aseptic precautions according to the existing standards were followed before, during and after the surgery. The subjects were treated as per the standard of care, after transferring to the observation room. Inflammation recording card was given to subjects after surgery to manually mark the level of pain, swelling and trismus, after onset of symptoms at the home. Follow-up visits were conducted regularly to verify subject’s well-being. The subjects were followed-up on Day 3, Day 7, Day 12, Day 30 and Month 3 post-surgery.
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figshare
创建时间:
2022-06-11
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