Diabetes Mellitus, Type 2PCSDMT2NCT06046976
Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2
A study testing piesosurgical extraction and conventional extraction in people with Diabetes Mellitus, Type 2 and Surgery, run by University of Belgrade at 1 site in Serbia.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Surgery, Tooth Extraction Status Nos
- What is being tested?
- piesosurgical extraction and conventional extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- 13 Jun 2022to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- multiple multi-rooted teeth indicated for extraction
- controlled DMT2
Who cannot join
- HbA1c >7%
- chronic orofacial pain and infection in orofacial region
- alcohol and tobacco consumption
- pregnant women and nursing mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia 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
- Being tested
- piesosurgical extraction, conventional extraction
- Keywords
- piesosurgery, exodontia, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piesosurgical extractionProcedure or surgery
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
conventional extractionProcedure or surgery
exodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Active comparator | Not described Receives: Procedure: piesosurgical extraction; Procedure: conventional extraction |
| Diabetes mellitus type 2 | Experimental | Not described Receives: Procedure: piesosurgical extraction; Procedure: conventional extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of osteotomy
Measured: from the start of procedure to the end of performing osteotomy
MicroRNA 21 (Mir-21) expression
Measured: during the first 24 hours after intervention
Secondary outcomes (13)
Duration of tooth sectioning
Measured: from the beginning of tooth sectioning to the end of tooth sectioning
Total exodontia time
Measured: 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)
Measured: 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.
Measured: 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
Measured: within 24 hours after procedure
First analgesic consumption
time from the end of the procedure until first analgesic consumption measured in minutes
Measured: 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
Measured: 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)
Measured: 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
Measured: within 21 days after procedure
Vascular Endothelial Growth Factor (VEGF) level
detected by Enzyme-Linked Immunosorbent Essay method
Measured: within 24 hours after intervention
Matrix Metalloproteinase 9 (MMP9) level
detected by Enzyme-Linked Immunosorbent Essay method
Measured: within 24 hours after intervention
Phosphatase and Tensin Homolog (PTEN) level
detected by Enzyme-Linked Immunosorbent Essay method
Measured: within 24 hours after intervention
Superoxide Dismutase(SOD) enzyme activity (%)
Activity level detected by spectrophotometry using SOD Assay kit
Measured: within 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start13 Jun 2022
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade
- Investigators
- Milan Vucetic, DDS PHD, Principal investigator, University of Belgrade Faculty of Dental MedicineBozidar Brkovic, DDS PhD, Study director, University of Belgrade Faculty of Dental MedicineMarija S Milic, DDS PhD, Principal investigator, University of Belgrade Faculty of Dental MedicineJelena Roganovic, DDS PhD, Principal investigator, University of Belgrade Faculty of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046976
- Sponsor's protocol ID
- 36/06
- Acronym
- PCSDMT2
- Status last verified
- Oct 2023
- First submitted
- 2 Dec 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT06046976
- Acronym / sponsor ID
- PCSDMT2 / 36/06
- Keywords
- piesosurgery, exodontia, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Active comparator | Procedure: piesosurgical extraction, Procedure: conventional extraction |
| Diabetes mellitus type 2 | Experimental | Procedure: piesosurgical extraction, Procedure: conventional extraction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- multiple multi-rooted teeth indicated for extraction
- controlled DMT2
Key exclusion criteria (4 listed)
- HbA1c >7%
- chronic orofacial pain and infection in orofacial region
- alcohol and tobacco consumption
- pregnant women and nursing mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| piesosurgical extractionexodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach | Procedure or surgery | Diabetes mellitus type 2, Healthy |
| conventional extractionexodontia of multi - rooted teeth in upper/lower jaw using piesosurgical approach | Procedure or surgery | Diabetes mellitus type 2, Healthy |
Primary outcome
Duration of osteotomy
Time frame: from the start of procedure to the end of performing osteotomy
MicroRNA 21 (Mir-21) expression
Time frame: during the first 24 hours after intervention
13 secondary outcomes
Duration of tooth sectioning
Time frame: from the beginning of tooth sectioning to the end of tooth sectioning
Total exodontia time
Time frame: from the beginning of surgical procedure to the end of tooth extraction
Pain intensity
Time frame: during the first 24 hours after intervention
Healing Index Score
Time frame: within 21 days after procedure
First postoperative pain report
Time frame: within 24 hours after procedure
First analgesic consumption
Time frame: within 24 hours after procedure
Clinical appearance of gingival tissue
Time frame: within 7 days after procedure
Residual Socket Volume
Time frame: within 21 days after procedure
Postextraction wound epithelization
Time frame: within 21 days after procedure
Vascular Endothelial Growth Factor (VEGF) level
Time frame: within 24 hours after intervention
Matrix Metalloproteinase 9 (MMP9) level
Time frame: within 24 hours after intervention
Phosphatase and Tensin Homolog (PTEN) level
Time frame: within 24 hours after intervention
Superoxide Dismutase(SOD) enzyme activity (%)
Time frame: within 24 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Yes
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan Vucetic, DDS PHD principal investigator
University of Belgrade Faculty of Dental Medicine
Bozidar Brkovic, DDS PhD study director
University of Belgrade Faculty of Dental Medicine
Marija S Milic, DDS PhD principal investigator
University of Belgrade Faculty of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing piesosurgical extraction and conventional extraction in people with Diabetes Mellitus, Type 2 and Surgery, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of osteotomy (time frame: from the start of procedure to the end of performing osteotomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.