NCT06046976CompletedNot Applicable
Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Belgrade
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- MicroRNA 21 (Mir-21) expression
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
MicroRNA 21 (Mir-21) expression
Time Frame: during the first 24 hours after intervention
Duration of osteotomy
Time Frame: from the start of procedure to the end of performing osteotomy
Secondary Outcomes
- Total exodontia time(from the beginning of surgical procedure to the end of tooth extraction)
- First analgesic consumption(within 24 hours after procedure)
- First postoperative pain report(within 24 hours after procedure)
- Pain intensity(during the first 24 hours after intervention)
- Duration of tooth sectioning(from the beginning of tooth sectioning to the end of tooth sectioning)
- Healing Index Score(within 21 days after procedure)
- Clinical appearance of gingival tissue(within 7 days after procedure)
- Vascular Endothelial Growth Factor (VEGF) level(within 24 hours after intervention)
- Phosphatase and Tensin Homolog (PTEN) level(within 24 hours after intervention)
- Superoxide Dismutase(SOD) enzyme activity (%)(within 24 hours after intervention)
- Matrix Metalloproteinase 9 (MMP9) level(within 24 hours after intervention)
- Residual Socket Volume(within 21 days after procedure)
- Postextraction wound epithelization(within 21 days after procedure)
Investigators
Bozidar Brkovic, DDS, MSc, PhD, Professor
DDS PhD, Professor
University of Belgrade
Study Sites (2)
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