Diabetes Mellitus, Type 2 Clinical Trial
— PCSDMT2Official title:
Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
NCT number | NCT06046976 |
Other study ID # | 36/06 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 13, 2022 |
Est. completion date | October 10, 2023 |
Verified date | October 2023 |
Source | University of Belgrade |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | October 10, 2023 |
Est. primary completion date | October 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Serbia | University of Belgrade Faculty of Dental Medicine | Belgrade |
Lead Sponsor | Collaborator |
---|---|
University of Belgrade |
Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of osteotomy | from the start of procedure to the end of performing osteotomy | ||
Primary | MicroRNA 21 (Mir-21) expression | during the first 24 hours after intervention | ||
Secondary | Duration of tooth sectioning | from the beginning of tooth sectioning to the end of tooth sectioning | ||
Secondary | Total exodontia time | from the beginning of surgical procedure to the end of tooth extraction | ||
Secondary | Pain intensity | Numerical Rating Scale, measuring pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable) | during the first 24 hours after intervention | |
Secondary | 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. | within 21 days after procedure | |
Secondary | First postoperative pain report | time between the end of procedure and first pain experienced by the patient measured in minutes | within 24 hours after procedure | |
Secondary | First analgesic consumption | time from the end of the procedure until first analgesic consumption measured in minutes | within 24 hours after procedure | |
Secondary | 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 | within 7 days after procedure | |
Secondary | 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) | within 21 days after procedure | |
Secondary | 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 | within 21 days after procedure | |
Secondary | Vascular Endothelial Growth Factor (VEGF) level | detected by Enzyme-Linked Immunosorbent Essay method | within 24 hours after intervention | |
Secondary | Matrix Metalloproteinase 9 (MMP9) level | detected by Enzyme-Linked Immunosorbent Essay method | within 24 hours after intervention | |
Secondary | Phosphatase and Tensin Homolog (PTEN) level | detected by Enzyme-Linked Immunosorbent Essay method | within 24 hours after intervention | |
Secondary | Superoxide Dismutase(SOD) enzyme activity (%) | Activity level detected by spectrophotometry using SOD Assay kit | within 24 hours after intervention |
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