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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Surgery; Tooth Extraction Status Nos
• Interventions: Procedure: piesosurgical extraction; Procedure: conventional extraction

• Registration Number: NCT06046976
• Lead Sponsor: University of Belgrade

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-13
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Status Verified: 2023-10
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy	conventional extraction	-
Healthy	piesosurgical extraction	-
Diabetes mellitus type 2	conventional extraction	-
Diabetes mellitus type 2	piesosurgical extraction	-

Primary Outcome Measures

Name	Time	Method
MicroRNA 21 (Mir-21) expression	during the first 24 hours after intervention
Duration of osteotomy	from the start of procedure to the end of performing osteotomy

Secondary Outcome Measures

Name	Time	Method
Total exodontia time	from the beginning of surgical procedure to the end of tooth extraction
First analgesic consumption	within 24 hours after procedure	time from the end of the procedure until first analgesic consumption measured in minutes
First postoperative pain report	within 24 hours after procedure	time between the end of procedure and first pain experienced by the patient measured in minutes
Pain intensity	during the first 24 hours after intervention	Numerical Rating Scale, measuring pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable)
Duration of tooth sectioning	from the beginning of tooth sectioning to the end of tooth sectioning
Healing Index Score	within 21 days after procedure	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.
Clinical appearance of gingival tissue	within 7 days after procedure	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
Vascular Endothelial Growth Factor (VEGF) level	within 24 hours after intervention	detected by Enzyme-Linked Immunosorbent Essay method
Phosphatase and Tensin Homolog (PTEN) level	within 24 hours after intervention	detected by Enzyme-Linked Immunosorbent Essay method
Superoxide Dismutase(SOD) enzyme activity (%)	within 24 hours after intervention	Activity level detected by spectrophotometry using SOD Assay kit
Matrix Metalloproteinase 9 (MMP9) level	within 24 hours after intervention	detected by Enzyme-Linked Immunosorbent Essay method
Residual Socket Volume	within 21 days after procedure	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	within 21 days after procedure	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

Trial Locations

Locations (1)

University of Belgrade Faculty of Dental Medicine; 🇷🇸 Belgrade, Serbia