An interventional study of piesosurgical extraction and conventional extraction in Diabetes Mellitus, Type 2, Surgery and Tooth Extraction Status Nos, sponsored by University of Belgrade. Completed at 1 site in Serbia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by University of Belgrade · Not applicable, Interventional, and Treatment
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Procedure: piesosurgical extraction · Procedure: conventional extraction
Procedure: piesosurgical extraction · Procedure: conventional extraction
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
Duration of osteotomy
Time frame: from the start of procedure to the end of performing osteotomy
MicroRNA 21 (Mir-21) expression
Time frame: during the first 24 hours after intervention
Duration of tooth sectioning
Time frame: from the beginning of tooth sectioning to the end of tooth sectioning
Total exodontia time
Time frame: from the beginning of surgical procedure to the end of tooth extraction
Pain intensity
Numerical Rating Scale, measuring pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable)
Time frame: during the first 24 hours after intervention
Healing Index Score
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 21 days after procedure
First postoperative pain report
time between the end of procedure and first pain experienced by the patient measured in minutes
Time frame: within 24 hours after procedure
First analgesic consumption
time from the end of the procedure until first analgesic consumption measured in minutes
Time frame: within 24 hours after procedure
Clinical appearance of gingival tissue
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 7 days after procedure
Residual Socket Volume
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
Postextraction wound epithelization
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 21 days after procedure
Vascular Endothelial Growth Factor (VEGF) level
detected by Enzyme-Linked Immunosorbent Essay method
Time frame: within 24 hours after intervention
Matrix Metalloproteinase 9 (MMP9) level
detected by Enzyme-Linked Immunosorbent Essay method
Time frame: within 24 hours after intervention
Phosphatase and Tensin Homolog (PTEN) level
detected by Enzyme-Linked Immunosorbent Essay method
Time frame: within 24 hours after intervention
Superoxide Dismutase(SOD) enzyme activity (%)
Activity level detected by spectrophotometry using SOD Assay kit
Time frame: within 24 hours after intervention
Plan to share: Yes
Supporting information: Study protocol, Sap
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University of Belgrade