Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2
PCSDMT2
Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2022
CompletedFirst Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2023
CompletedOctober 31, 2023
October 1, 2023
1.3 years
December 2, 2022
October 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (13)
Duration of tooth sectioning
from the beginning of tooth sectioning to the end of tooth sectioning
Total exodontia time
from the beginning of surgical procedure to the end of tooth extraction
Pain intensity
during the first 24 hours after intervention
Healing Index Score
within 21 days after procedure
First postoperative pain report
within 24 hours after procedure
- +8 more secondary outcomes
Study Arms (2)
Healthy
ACTIVE COMPARATORDiabetes mellitus type 2
EXPERIMENTALInterventions
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
Eligibility Criteria
You may qualify if:
- multiple multi-rooted teeth indicated for extraction
- controlled DMT2
You may not qualify if:
- HbA1c \>7%
- chronic orofacial pain and infection in orofacial region
- alcohol and tobacco consumption
- pregnant women and nursing mothers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Belgrade Faculty of Dental Medicine
Belgrade, 11000, Serbia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Milan Vucetic, DDS PHD
University of Belgrade Faculty of Dental Medicine
- STUDY DIRECTOR
Bozidar Brkovic, DDS PhD
University of Belgrade Faculty of Dental Medicine
- PRINCIPAL INVESTIGATOR
Marija S Milic, DDS PhD
University of Belgrade Faculty of Dental Medicine
- PRINCIPAL INVESTIGATOR
Jelena Roganovic, DDS PhD
University of Belgrade Faculty of Dental Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS PhD, Professor
Study Record Dates
First Submitted
December 2, 2022
First Posted
September 21, 2023
Study Start
June 13, 2022
Primary Completion
October 10, 2023
Study Completion
October 10, 2023
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP