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Clinical Trials/NCT06046976
NCT06046976CompletedNot Applicable

Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2

University of Belgrade2 sites in 1 country60 target enrollmentStarted: June 13, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
MicroRNA 21 (Mir-21) expression
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bozidar Brkovic, DDS, MSc, PhD, Professor

DDS PhD, Professor

University of Belgrade

Study Sites (2)

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