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Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2 (PCSDMT2)

Primary Purpose

Diabetes Mellitus, Type 2, Surgery, Tooth Extraction Status Nos

Status
Recruiting
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
piesosurgical extraction
conventional extraction
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring piesosurgery, exodontia, diabetes mellitus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Belgrade Faculty of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy

Diabetes mellitus type 2

Arm Description

Outcomes

Primary Outcome Measures

Duration of osteotomy
MicroRNA 21 (Mir-21) expression

Secondary Outcome Measures

Duration of tooth sectioning
Total exodontia time
Pain intensity
Numerical Rating Scale, measuring pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable)
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.
First postoperative pain report
time between the end of procedure and first pain experienced by the patient measured in minutes
First analgesic consumption
time from the end of the procedure until first analgesic consumption measured in minutes
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
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)
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
Vascular Endothelial Growth Factor (VEGF) level
detected by Enzyme-Linked Immunosorbent Essay method
Matrix Metalloproteinase 9 (MMP9) level
detected by Enzyme-Linked Immunosorbent Essay method
Phosphatase and Tensin Homolog (PTEN) level
detected by Enzyme-Linked Immunosorbent Essay method
Superoxide Dismutase(SOD) enzyme activity (%)
Activity level detected by spectrophotometry using SOD Assay kit

Full Information

First Posted
December 2, 2022
Last Updated
October 11, 2023
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT06046976
Brief Title
Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2
Acronym
PCSDMT2
Official Title
Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
October 10, 2023 (Actual)
Study Completion Date
October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Surgery, Tooth Extraction Status Nos
Keywords
piesosurgery, exodontia, diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Active Comparator
Arm Title
Diabetes mellitus type 2
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
piesosurgical extraction
Intervention Description
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
Intervention Type
Procedure
Intervention Name(s)
conventional extraction
Intervention Description
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
Primary Outcome Measure Information:
Title
Duration of osteotomy
Time Frame
from the start of procedure to the end of performing osteotomy
Title
MicroRNA 21 (Mir-21) expression
Time Frame
during the first 24 hours after intervention
Secondary Outcome Measure Information:
Title
Duration of tooth sectioning
Time Frame
from the beginning of tooth sectioning to the end of tooth sectioning
Title
Total exodontia time
Time Frame
from the beginning of surgical procedure to the end of tooth extraction
Title
Pain intensity
Description
Numerical Rating Scale, measuring pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable)
Time Frame
during the first 24 hours after intervention
Title
Healing Index Score
Description
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.
Time Frame
within 21 days after procedure
Title
First postoperative pain report
Description
time between the end of procedure and first pain experienced by the patient measured in minutes
Time Frame
within 24 hours after procedure
Title
First analgesic consumption
Description
time from the end of the procedure until first analgesic consumption measured in minutes
Time Frame
within 24 hours after procedure
Title
Clinical appearance of gingival tissue
Description
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
Time Frame
within 7 days after procedure
Title
Residual Socket Volume
Description
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)
Time Frame
within 21 days after procedure
Title
Postextraction wound epithelization
Description
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
Time Frame
within 21 days after procedure
Title
Vascular Endothelial Growth Factor (VEGF) level
Description
detected by Enzyme-Linked Immunosorbent Essay method
Time Frame
within 24 hours after intervention
Title
Matrix Metalloproteinase 9 (MMP9) level
Description
detected by Enzyme-Linked Immunosorbent Essay method
Time Frame
within 24 hours after intervention
Title
Phosphatase and Tensin Homolog (PTEN) level
Description
detected by Enzyme-Linked Immunosorbent Essay method
Time Frame
within 24 hours after intervention
Title
Superoxide Dismutase(SOD) enzyme activity (%)
Description
Activity level detected by spectrophotometry using SOD Assay kit
Time Frame
within 24 hours after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bozidar Brkovic, DDS PhD
Phone
+381112685424
Email
brkovic73@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Milan Vucetic, DDS PhD
Phone
+381112685424
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milan Vucetic, DDS PHD
Organizational Affiliation
University of Belgrade Faculty of Dental Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bozidar Brkovic, DDS PhD
Organizational Affiliation
University of Belgrade Faculty of Dental Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marija S Milic, DDS PhD
Organizational Affiliation
University of Belgrade Faculty of Dental Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jelena Roganovic, DDS PhD
Organizational Affiliation
University of Belgrade Faculty of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Belgrade Faculty of Dental Medicine
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bozidar Brkovic, DDSPhD
Phone
+381112685424
Email
brkovic73@yahoo.com
First Name & Middle Initial & Last Name & Degree
Bozidar Brkovic, DDSPhD
First Name & Middle Initial & Last Name & Degree
Milan Vucetic, DDS PhD
First Name & Middle Initial & Last Name & Degree
Jelena Roganovic, DDS PhD
First Name & Middle Initial & Last Name & Degree
Marija S Milic, DDS PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2

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