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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Surgery; Tooth Extraction Status Nos
• Intervention / Treatment: Procedure: piesosurgical extraction; Procedure: conventional extraction

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • University of Belgrade Faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy	Procedure: piesosurgical extraction; exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach; Procedure: conventional extraction; exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
Experimental: Diabetes mellitus type 2	Procedure: piesosurgical extraction; exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach; Procedure: conventional extraction; exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Numerical Rating Scale, measuring pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable)	during the first 24 hours after intervention
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.	within 21 days after procedure
First postoperative pain report	time between the end of procedure and first pain experienced by the patient measured in minutes	within 24 hours after procedure
First analgesic consumption	time from the end of the procedure until first analgesic consumption measured in minutes	within 24 hours after procedure
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	within 7 days after procedure
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)	within 21 days after procedure
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	within 21 days after procedure
Vascular Endothelial Growth Factor (VEGF) level	detected by Enzyme-Linked Immunosorbent Essay method	within 24 hours after intervention
Matrix Metalloproteinase 9 (MMP9) level	detected by Enzyme-Linked Immunosorbent Essay method	within 24 hours after intervention
Phosphatase and Tensin Homolog (PTEN) level	detected by Enzyme-Linked Immunosorbent Essay method	within 24 hours after intervention
Superoxide Dismutase(SOD) enzyme activity (%)	Activity level detected by spectrophotometry using SOD Assay kit	within 24 hours after intervention

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: diabetes mellitus; exodontia; piesosurgery
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 36/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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