University of Belgrade Faculty of Dental Medicine
Belgrade, 11000, Serbia
NCT Number: NCT06046976
This study will evaluateand compare intraoperative and postoperative clinical parameters related to discomfort and wound heeling, as well as laboratory wound healing parameters after piezosurgical and conventional surgery approach during complex exodontia in healthy and patients with Diabetes Mellitus Type 2
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Belgrade, 11000, Serbia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
Time frame: from the start of procedure to the end of performing osteotomy
Time frame: during the first 24 hours after intervention
Time frame: from the beginning of tooth sectioning to the end of tooth sectioning
Time frame: from the beginning of surgical procedure to the end of tooth extraction
Time frame: during the first 24 hours after intervention
Numerical Rating Scale, measuring pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable)
Time frame: within 21 days after procedure
3 scoring levels for each of the 4 parameters considered: tissue color (1 = 100% of gingiva pink; 2 = <50% of gingiva red, hyper- emic, movable; 3 = >50% of gingiva red, hyperemic, movable), color and consistency of the healing tissue (1 = close grained, pink; 2 = soft, red; 3 = fragile, greenish or grayish), suppuration (1 = absent; 2 = absent but pronounced amount of plaque around socket walls; 3 = pronounced), and bleeding (1 = absent; 2 = induced by palpation; 3 = spontaneous). Thus, the scoring scale ranged from 4, corresponding to excellent healing, to 12, indicating severely impaired healing.
Time frame: within 24 hours after procedure
time between the end of procedure and first pain experienced by the patient measured in minutes
Time frame: within 24 hours after procedure
time from the end of the procedure until first analgesic consumption measured in minutes
Time frame: within 7 days after procedure
clinical appearance of the soft tissues (Visual Analogue Scale 0 to 3, according to the color and presence of edema and bleeding; ie, 0, normally pink, not edematous; 1, pink-red, slightly edematous; 2, red, edematous; and 3, red, edematous, bled easily when touched
Time frame: within 21 days after procedure
the residual socket volume (RSV) is the fraction of the postextraction original cavity still open at each follow-up session (t = 3, 7, 14, and 21 days), computed as the ratio of mesiodistal (MD), bucolingual (BL) and socket depth (SD) at the follow-up session to the baseline value (t=0), measured after extraction (perfect closure corresponds to RSV = 0.00)
Time frame: within 21 days after procedure
Epithelialization was measured as bucolingual and mesiodistal diameter of the extraction socket during the follow-up (3, 7, 14 and 21 postoperative day), expressed in millimeters
Time frame: within 24 hours after intervention
detected by Enzyme-Linked Immunosorbent Essay method
Time frame: within 24 hours after intervention
detected by Enzyme-Linked Immunosorbent Essay method
Time frame: within 24 hours after intervention
detected by Enzyme-Linked Immunosorbent Essay method
Time frame: within 24 hours after intervention
Activity level detected by spectrophotometry using SOD Assay kit
University of Belgrade
Other
Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
Acronym: PCSDMT2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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