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Completed

NCT Number: NCT06046976

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Belgrade Faculty of Dental Medicine

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

piesosurgical extraction

Procedure

exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach

conventional extraction

Procedure

exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach

Primary outcomes

  1. Duration of osteotomy

    Time frame: from the start of procedure to the end of performing osteotomy

  2. MicroRNA 21 (Mir-21) expression

    Time frame: during the first 24 hours after intervention

Secondary outcomes

  1. Duration of tooth sectioning

    Time frame: from the beginning of tooth sectioning to the end of tooth sectioning

  2. Total exodontia time

    Time frame: from the beginning of surgical procedure to the end of tooth extraction

  3. Pain intensity

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: within 24 hours after intervention

    detected by Enzyme-Linked Immunosorbent Essay method

  11. Matrix Metalloproteinase 9 (MMP9) level

    Time frame: within 24 hours after intervention

    detected by Enzyme-Linked Immunosorbent Essay method

  12. Phosphatase and Tensin Homolog (PTEN) level

    Time frame: within 24 hours after intervention

    detected by Enzyme-Linked Immunosorbent Essay method

  13. Superoxide Dismutase(SOD) enzyme activity (%)

    Time frame: within 24 hours after intervention

    Activity level detected by spectrophotometry using SOD Assay kit

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

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

Acronym: PCSDMT2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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