PCSDMT2: Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2

• Sponsor: University of Belgrade (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06046976
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.6
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Surgery; Tooth Extraction Status Nos	Procedure: piesosurgical extraction; Procedure: conventional extraction	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
• Actual Study Start Date: Jun 13, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Duration of osteotomy [from the start of procedure to the end of performing osteotomy]

2. MicroRNA 21 (Mir-21) expression [during the first 24 hours after intervention]

Secondary Outcome Measures

1. Duration of tooth sectioning [from the beginning of tooth sectioning to the end of tooth sectioning]

2. Total exodontia time [from the beginning of surgical procedure to the end of tooth extraction]

3. 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)

4. 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.

5. 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

6. First analgesic consumption [within 24 hours after procedure]

   time from the end of the procedure until first analgesic consumption measured in minutes

7. 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

8. 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)

9. 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

10. Vascular Endothelial Growth Factor (VEGF) level [within 24 hours after intervention]

    detected by Enzyme-Linked Immunosorbent Essay method

11. Matrix Metalloproteinase 9 (MMP9) level [within 24 hours after intervention]

    detected by Enzyme-Linked Immunosorbent Essay method

12. Phosphatase and Tensin Homolog (PTEN) level [within 24 hours after intervention]

    detected by Enzyme-Linked Immunosorbent Essay method

13. Superoxide Dismutase(SOD) enzyme activity (%) [within 24 hours after intervention]

    Activity level detected by spectrophotometry using SOD Assay kit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Belgrade Faculty of Dental Medicine	Belgrade		Serbia	11000

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bozidar Brkovic, DDS, MSc, PhD, Professor, DDS PhD, Professor, University of Belgrade
• ClinicalTrials.gov Identifier: NCT06046976
• Other Study ID Numbers: 36/06
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Bozidar Brkovic, DDS, MSc, PhD, Professor, DDS PhD, Professor, University of Belgrade: piesosurgery; exodontia; diabetes mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 21, 2023