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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06046976
Other study ID # 36/06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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