Diabetes Mellitus, Type 2, Surgery, Tooth Extraction Status Nos
Conditions
Keywords
piesosurgery, exodontia, diabetes mellitus
Brief summary
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
Interventions
PROCEDUREpiesosurgical extraction
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
PROCEDUREconventional extraction
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* multiple multi-rooted teeth indicated for extraction * controlled DMT2
Exclusion criteria
* HbA1c \>7% * chronic orofacial pain and infection in orofacial region * alcohol and tobacco consumption * pregnant women and nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of osteotomy | from the start of procedure to the end of performing osteotomy |
| MicroRNA 21 (Mir-21) expression | during the first 24 hours after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | during the first 24 hours after intervention | Numerical Rating Scale, measuring pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable) |
| Healing Index Score | 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. |
| First postoperative pain report | within 24 hours after procedure | time between the end of procedure and first pain experienced by the patient measured in minutes |
| First analgesic consumption | within 24 hours after procedure | time from the end of the procedure until first analgesic consumption measured in minutes |
| Clinical appearance of gingival tissue | 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 |
| Duration of tooth sectioning | from the beginning of tooth sectioning to the end of tooth sectioning | — |
| Postextraction wound epithelization | 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 |
| Vascular Endothelial Growth Factor (VEGF) level | within 24 hours after intervention | detected by Enzyme-Linked Immunosorbent Essay method |
| Matrix Metalloproteinase 9 (MMP9) level | within 24 hours after intervention | detected by Enzyme-Linked Immunosorbent Essay method |
| Phosphatase and Tensin Homolog (PTEN) level | within 24 hours after intervention | detected by Enzyme-Linked Immunosorbent Essay method |
| Superoxide Dismutase(SOD) enzyme activity (%) | within 24 hours after intervention | Activity level detected by spectrophotometry using SOD Assay kit |
| Residual Socket Volume | 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) |
| Total exodontia time | from the beginning of surgical procedure to the end of tooth extraction | — |
Countries
Serbia
Outcome results
None listed