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

Study Overview
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Brief Summary
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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

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

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

Intervention / Treatment
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* Procedure: piesosurgical extraction
* Procedure: conventional extraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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piesosurgery, exodontia, diabetes mellitus