Clinical trial NCT06046976: Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2
Official title: Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Surgery
Tooth Extraction Status Nos
Keywords: piesosurgery
exodontia
diabetes mellitus
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Duration of osteotomy
timeFrame: from the start of procedure to the end of performing osteotomy
measure: MicroRNA 21 (Mir-21) expression
timeFrame: during the first 24 hours after intervention
Secondary outcomes:
measure: Duration of tooth sectioning
timeFrame: from the beginning of tooth sectioning to the end of tooth sectioning
measure: Total exodontia time
timeFrame: from the beginning of surgical procedure to the end of tooth extraction
measure: Pain intensity
timeFrame: during the first 24 hours after intervention
measure: Healing Index Score
timeFrame: within 21 days after procedure
measure: First postoperative pain report
timeFrame: within 24 hours after procedure
measure: First analgesic consumption
timeFrame: within 24 hours after procedure
measure: Clinical appearance of gingival tissue
timeFrame: within 7 days after procedure
measure: Residual Socket Volume
timeFrame: within 21 days after procedure
measure: Postextraction wound epithelization
timeFrame: within 21 days after procedure
measure: Vascular Endothelial Growth Factor (VEGF) level
timeFrame: within 24 hours after intervention
measure: Matrix Metalloproteinase 9 (MMP9) level
timeFrame: within 24 hours after intervention
measure: Phosphatase and Tensin Homolog (PTEN) level
timeFrame: within 24 hours after intervention
measure: Superoxide Dismutase(SOD) enzyme activity (%)
timeFrame: within 24 hours after intervention
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: University of Belgrade Faculty of Dental Medicine
Study officials:
affiliation: University of Belgrade Faculty of Dental Medicine
name: Milan Vucetic, DDS PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Belgrade Faculty of Dental Medicine
name: Bozidar Brkovic, DDS PhD
role: STUDY_DIRECTOR
affiliation: University of Belgrade Faculty of Dental Medicine
name: Marija S Milic, DDS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Belgrade Faculty of Dental Medicine
name: Jelena Roganovic, DDS PhD
role: PRINCIPAL_INVESTIGATOR
References: