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

Diabetes Mellitus, Type 2 Clinical Trial

— PCSDMT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06046976
• Other study ID #: 36/06
• Status: Completed
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: October 10, 2023

Study information

• Verified date: October 2023
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• piesosurgical extraction
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
• conventional extraction
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach

Locations

Country	Name	City	State
Serbia	University of Belgrade Faculty of Dental Medicine	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of osteotomy		from the start of procedure to the end of performing osteotomy
Primary	MicroRNA 21 (Mir-21) expression		during the first 24 hours after intervention
Secondary	Duration of tooth sectioning		from the beginning of tooth sectioning to the end of tooth sectioning
Secondary	Total exodontia time		from the beginning of surgical procedure to the end of tooth extraction
Secondary	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
Secondary	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
Secondary	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
Secondary	First analgesic consumption	time from the end of the procedure until first analgesic consumption measured in minutes	within 24 hours after procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Vascular Endothelial Growth Factor (VEGF) level	detected by Enzyme-Linked Immunosorbent Essay method	within 24 hours after intervention
Secondary	Matrix Metalloproteinase 9 (MMP9) level	detected by Enzyme-Linked Immunosorbent Essay method	within 24 hours after intervention
Secondary	Phosphatase and Tensin Homolog (PTEN) level	detected by Enzyme-Linked Immunosorbent Essay method	within 24 hours after intervention
Secondary	Superoxide Dismutase(SOD) enzyme activity (%)	Activity level detected by spectrophotometry using SOD Assay kit	within 24 hours after intervention