The Effect of Different Hemostatic Agents on Hemorrhage Control, Pain and Quality of Life After E… (NCT07311291) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Different Hemostatic Agents on Hemorrhage Control, Pain and Quality of Life After Endodontic Microsurgery.
Italy34 participantsStarted 2025-02-27
Plain-language summary
Background This randomized clinical trial evaluated the effect of two different hemostatic materials for endodontic microsurgery on bleeding control, postoperative pain and patients' quality of life.
Methods Thirty-four subjects affected by apical periodontitis with clinical and radiographical indications for endodontic microsurgery were randomly divided into two groups: in the first group (n=15) a surgical glue was tested and in the second group (n=19) the ferric sulfate was used for hemostasis. The bleeding and the surgical field visibility during the intervention were evaluated. The postoperative pain and quality of life (QoL) was recorded through a numerical rating scale (NRS) and an Oral Health Impact Profile-14 (OHIP-14) questionnaire for seven days. The number of analgesics consumed during the same intervals was also recorded. Statistical analysis was performed using the Chi-Square test, Mann-Whitney test, and Fisher t-test (P=0.05).
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Consecutive informed and consenting healthy subjects (ASA 1-2) of both genders with no medical history of systemic disease and presenting a diagnosis of symptomatic or asymptomatic apical periodontitis in correspondence of endodontically treated teeth with medium (2-5 mm3) and large (≥5 mm3) periapical lesions.
* Subjects with periapical defects with one or two residual cortical walls.
* Subjects with clinical indications for retrograde endodontic retreatment: teeth presenting inadequate root canal treatment with periapical radiolucency and impossible access through orthograde retreatment due to the presence of prosthetic restorations, posts, canal blocks and ledges.
* Subjects with teeth presenting an adequate coronal seal and absence of pathological periodontal records.
Exclusion Criteria:
* Subjects affected by diabetes mellitus.
* Subjects affected by hypertension.
* Subjects affected by hepatic or renal diseases.
* Subjects affected by bleeding disorders, antiplatelet or anticoagulant therapy.
* Women experiencing pregnancy.
* Subjects with teeth considered not restorable.
* Subjects with dental elements affected by fractures.
* Subjects with dental elements affected by extensive periodontal defects.
* Subjects with bone cavity designs with no residual cortical walls.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.