Diabetes Mellitus Type 2NCT07647406
Intraseptal and Periodontal Ligament Anaesthesia for Tooth Extraction in Patients With Type 2 Diabetes
A study testing Intraseptal anaesthesia (ISA) and Periodontal ligament anaesthesia (PLA) in people with Diabetes Mellitus Type 2, run by University of Business Academy in Novi Sad, Serbia at 1 site in Serbia.
Trial summary
The goal of this clinical trial is to compare two local anesthesia techniques, intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA), in patients with controlled type 2 diabetes mellitus undergoing tooth extraction. Read more about this study
- Who is it for?
- Ages 35 to 77 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Intraseptal anaesthesia (ISA) and Periodontal ligament anaesthesia (PLA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSerbia
- Study dates
- 11 Jan 2026to 27 May 2026
- 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 35 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Controlled Type 2 diabetes mellitus
- Age 35-77 years
- Patients requiring extraction of maxillary lateral incisors or mandibular first premolars
- Teeth free of acute periodontal disease
- No acute dentoalveolar abscess
- No dental treatment within last 48 hours
Show all 9Show fewer
- No smoking
- No alcohol or drug dependence
- No contraindications to local anesthetic or vasoconstrictor
Who cannot join
- Smokers
- Patients with alcohol or drug dependence
- Contraindications to local anesthetics or vasoconstrictors
- Acute periodontal disease at the site of injection
- Acute dentoalveolar abscess
- History of tooth trauma or hypersensitivity in target teeth
- Dental treatment within the last 48 hours prior to procedure
- Non-controlled diabetes mellitus (implied, since study includes controlled DM only
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Faculty of Dentistry in Pančevo, University of Business Academy in Novi Sad
Pančevo, Vojvodina
About this study
Official title: Efficacy and Safety of Intraseptal and Periodontal Ligament Anaesthesia for Extraction of Upper Lateral Incisors and Lower First Premolars in Patients With Type 2 Diabetes Mellitus
The goal of this clinical trial is to compare two local anesthesia techniques, intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA), in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
The main questions it aims to answer are:
Read more
Which technique provides more effective local anesthesia for tooth extraction? Do ISA and PLA differ in their effects on blood pressure and heart rate during the procedure?
Researchers will compare ISA and PLA to determine which method is more effective and safer in this patient population.
Participants will:
Receive local anesthesia (ISA or PLA) using articaine with epinephrine delivered with a computer-controlled system Undergo extraction of a maxillary lateral incisor or mandibular first premolar Have blood pressure and heart rate measured before, during, and after anesthesia and extraction
Read the detailed description
This randomized clinical trial was designed to evaluate and compare the clinical efficacy and safety of intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA) in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
Local anesthetic administration in diabetic patients requires careful consideration due to potential cardiovascular responses and altered tissue sensitivity. Alternative injection techniques such as ISA and PLA may provide effective anesthesia while minimizing systemic effects.
A total of 120 participants were randomly assigned to receive either ISA or PLA. All anesthetic procedures were performed using a computer-controlled local anesthetic delivery system (CCLADS) with 0.6 mL of 4% articaine with 1:100,000 epinephrine (Septanest).
The study included extraction of maxillary lateral incisors and mandibular first premolars. Outcomes included anesthetic success rate, onset time, duration and extent of anesthesia, as well as changes in systolic and diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after the procedure.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Intraseptal anaesthesia (ISA), Periodontal ligament anaesthesia (PLA)
- Keywords
- intraseptal anaesthesia (ISA), periodontal ligament anaesthesia (PLA), type 2 diabetes mellitus, articaine with epinephrine, local anaesthesia, CCLADS
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraseptal anaesthesia (ISA)Procedure or surgery
0.6 mL of 4% articaine with 1:100,000 epinephrine administered for intraseptal anaesthesia (ISA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
Periodontal ligament anaesthesia (PLA)Procedure or surgery
0.6 mL of 4% articaine with 1:100,000 epinephrine administered for periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
| Study group | Role | What they receive |
|---|---|---|
| ISA (Intraseptal Anaesthesia) | Experimental | Participants received intraseptal anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. Receives: Procedure: Intraseptal anaesthesia (ISA) |
| PLA (Periodontal Ligament Anaesthesia) | Experimental | Participants received periodontal ligament anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. Receives: Procedure: Periodontal ligament anaesthesia (PLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic success rate
Anesthetic success rate of intraseptal anaesthesia (ISA) compared with periodontal ligament anaesthesia (PLA) during extraction of maxillary lateral incisors and mandibular first premolars in patients with controlled Type 2 diabetes mellitus.
Measured: During tooth extraction procedure (5 minutes after administration of local anaesthesia).
Secondary outcomes (7)
Onset time of local anesthesia
Time from completion of anesthetic injection to the establishment of profound anesthesia in adjacent gingival tissue.
Measured: Immediately after administration of local anesthesia (during procedure)
Duration of soft tissue anesthesia
Time period from onset of anesthesia until return of sensation confirmed by pinprick testing in buccal attached gingiva.
Measured: During and after procedure (measured at 5-minute intervals until sensation returns)
Width of anesthetic field
Extent (in millimeters) of anesthetized area in buccal/lingual/palatal attached gingiva and oral mucosa measured using pinprick testing and a flexible ruler.
Measured: 10 minutes after successful anesthesia
Systolic blood pressure changes
Changes in systolic blood pressure before, during, and after administration of local anesthesia.
Measured: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
Diastolic blood pressure changes
Changes in diastolic blood pressure during perioperative period of anesthesia administration.
Measured: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
Mean arterial pressure changes
Changes in mean arterial pressure during and after administration of local anesthesia.
Measured: Baseline to 30 minutes post-injection
Heart rate changes
Changes in heart rate during and after administration of local anesthesia using ECG monitoring.
Measured: Baseline, during injection, and 5, 10, 15, 30 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start11 Jan 2026
- Primary completion17 Apr 2026
- Study completion27 May 2026
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
- Parallel groups
- Model description
- Participants with controlled Type 2 diabetes mellitus were randomly assigned to receive either intraseptal anaesthesia (ISA) or periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system. The study compared the two interventions in a parallel-group design during tooth extraction procedures.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Business Academy in Novi Sad, Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Biocanin, University of Business Academy in Novi Sad, Serbia
- Investigators
- Vladimir Biocanin, Principal investigator, Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647406
- Sponsor's protocol ID
- No.36/3
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared in order to protect participant privacy and ensure compliance with data protection regulations. Only summarized data will be made available in published results.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intraseptal and Periodontal Ligament Anaesthesia for Extraction of Upper Lateral Incisors and Lower First Premolars in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07647406
- Acronym / sponsor ID
- No.36/3
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- intraseptal anaesthesia (ISA), periodontal ligament anaesthesia (PLA), type 2 diabetes mellitus, articaine with epinephrine, local anaesthesia, CCLADS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Business Academy in Novi Sad, SerbiaUniversity, hospital or other
- Study start
- 11 Jan 2026 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 15 Jun 2026 (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.
The goal of this clinical trial is to compare two local anesthesia techniques, intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA), in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
The main questions it aims to answer are:
Which technique provides more effective local anesthesia for tooth extraction? Do ISA and PLA differ in their effects on blood pressure and heart rate during the procedure?
Researchers will compare ISA and PLA to determine which method is more effective and safer in this patient population.
Participants will:
Receive local anesthesia (ISA or PLA) using articaine with epinephrine delivered with a computer-controlled system Undergo extraction of a maxillary lateral incisor or mandibular first premolar Have blood pressure and heart rate measured before, during, and after anesthesia and extraction
Detailed description
This randomized clinical trial was designed to evaluate and compare the clinical efficacy and safety of intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA) in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
Local anesthetic administration in diabetic patients requires careful consideration due to potential cardiovascular responses and altered tissue sensitivity. Alternative injection techniques such as ISA and PLA may provide effective anesthesia while minimizing systemic effects.
A total of 120 participants were randomly assigned to receive either ISA or PLA. All anesthetic procedures were performed using a computer-controlled local anesthetic delivery system (CCLADS) with 0.6 mL of 4% articaine with 1:100,000 epinephrine (Septanest).
The study included extraction of maxillary lateral incisors and mandibular first premolars. Outcomes included anesthetic success rate, onset time, duration and extent of anesthesia, as well as changes in systolic and diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with controlled Type 2 diabetes mellitus were randomly assigned to receive either intraseptal anaesthesia (ISA) or periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system. The study compared the two interventions in a parallel-group design during tooth extraction procedures.
| Arm | Type | Receives |
|---|---|---|
| ISA (Intraseptal Anaesthesia) | Experimental | Procedure: Intraseptal anaesthesia (ISA)Participants received intraseptal anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. |
| PLA (Periodontal Ligament Anaesthesia) | Experimental | Procedure: Periodontal ligament anaesthesia (PLA)Participants received periodontal ligament anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. |
Who may qualify
- Ages
- 35 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Controlled Type 2 diabetes mellitus
- Age 35-77 years
- Patients requiring extraction of maxillary lateral incisors or mandibular first premolars
- Teeth free of acute periodontal disease
- No acute dentoalveolar abscess
Key exclusion criteria (8 listed)
- Smokers
- Patients with alcohol or drug dependence
- Contraindications to local anesthetics or vasoconstrictors
- Acute periodontal disease at the site of injection
- Acute dentoalveolar abscess
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 |
|---|---|---|
| Intraseptal anaesthesia (ISA)0.6 mL of 4% articaine with 1:100,000 epinephrine administered for intraseptal anaesthesia (ISA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. | Procedure or surgery | ISA (Intraseptal Anaesthesia) |
| Periodontal ligament anaesthesia (PLA)0.6 mL of 4% articaine with 1:100,000 epinephrine administered for periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. | Procedure or surgery | PLA (Periodontal Ligament Anaesthesia) |
Primary outcome
Anesthetic success rate
Time frame: During tooth extraction procedure (5 minutes after administration of local anaesthesia).
Anesthetic success rate of intraseptal anaesthesia (ISA) compared with periodontal ligament anaesthesia (PLA) during extraction of maxillary lateral incisors and mandibular first premolars in patients with controlled Type 2 diabetes mellitus.
7 secondary outcomes
Onset time of local anesthesia
Time frame: Immediately after administration of local anesthesia (during procedure)
Duration of soft tissue anesthesia
Time frame: During and after procedure (measured at 5-minute intervals until sensation returns)
Width of anesthetic field
Time frame: 10 minutes after successful anesthesia
Systolic blood pressure changes
Time frame: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
Diastolic blood pressure changes
Time frame: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
Mean arterial pressure changes
Time frame: Baseline to 30 minutes post-injection
Heart rate changes
Time frame: Baseline, during injection, and 5, 10, 15, 30 minutes after administration
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 16 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be shared in order to protect participant privacy and ensure compliance with data protection regulations. Only summarized data will be made available in published results.
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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.
Vladimir Biocanin principal investigator
Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraseptal anaesthesia (ISA) and Periodontal ligament anaesthesia (PLA) in people with Diabetes Mellitus Type 2, run by University of Business Academy in Novi Sad, Serbia 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 9 inclusion and 8 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 16 Jun 2026. 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?
Anesthetic success rate (time frame: During tooth extraction procedure (5 minutes after administration of local anaesthesia).). 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 16 Jun 2026.