PeriodontitisNCT07212270
Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures
A study testing periodontal flap surgery and gingivectomy and gingivoplasty in people with Periodontitis and Gingivitis and Periodontal Diseases, run by University of Belgrade at 1 site in Serbia.
Trial summary
The primary aim of this study is to evaluate the efficacy of intraseptal anesthesia using 0.3 mL of 4% articaine with 1:100,000 epinephrine (4% Ar+Ep) for periodontal flap surgery in patients with periodontitis and for gingivectomy/ gingivoplasty for the excision of hyperplastic gingival enlargements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Gingivitis and Periodontal Diseases
- What is being tested?
- periodontal flap surgery and gingivectomy and gingivoplasty
- 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
- 22 Sep 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years good systemic health
- gingivitis or periodontitis stage II and III
- at least 20 teeth present.
Who cannot join
- allergy to 4%Ar+Ep
- pregnant or lactating females
- medication uptake and diseases affecting the periodontal tissues
- acute pain, swelling, and presence of gingival lesions.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
Belgrade, 11000
About this study
The primary aim of this study is to evaluate the efficacy of intraseptal anesthesia using 0.3 mL of 4% articaine with 1:100,000 epinephrine (4% Ar+Ep) for periodontal flap surgery in patients with periodontitis and for gingivectomy/ gingivoplasty for the excision of hyperplastic gingival enlargements. The secondary aim is to compare clinical anesthetic parameters between the ISA and conventional anesthesia techniques.
Read the detailed description
In the test groups every patient is going to receive injections of 0.3 mL of 4% articaine with 1: 100,000 epinephrine (ORABLOC ® , 40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy), with a computer controlled anesthesia delivery system (Anaeject®, Septodont, Sallanches, France). In the control groups all surgical procedures is going to be performed under infiltration anesthesia, as commonly used in periodontal surgery. The success rate and the anesthetic field widths is going to be recorded by pinprick testing. The pain levels will be recorded using the Visual Analogue Scale (VAS) for the administration of anesthesia, during the surgical procedure and after the intervention.
- Conditions
- Periodontitis, Gingivitis and Periodontal Diseases
- Being tested
- periodontal flap surgery, gingivectomy and gingivoplasty
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal flap surgeryProcedure or surgery
Open flap debridement with intra-sulcular incisions or flaps with para-marginal incisions were performed by lifting the mucoperiosteal flap and debriding the periodontal defect under visual control.
gingivectomy and gingivoplastyProcedure or surgery
surgical methods for the excision of hyperplastically enlarged gingiva.
| Study group | Role | What they receive |
|---|---|---|
| GG test | Experimental | Patient subjected to gingivectomy and gingivoplasty interventions and anesthesia of choice is intraseptal anesthesia. Receives: Procedure: gingivectomy and gingivoplasty |
| GG control | Active comparator | Patient subjected to gingivectomy and gingivoplasty interventions under the local infiltration anesthesia. Receives: Procedure: gingivectomy and gingivoplasty |
| PF test | Experimental | Patients undergoing periodontal flap surgery under the intraseptal anesthesia. Receives: Procedure: periodontal flap surgery |
| PF control | Active comparator | Patients undergoing periodontal flap surgery under the local infiltration anesthesia. Receives: Procedure: periodontal flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The anesthetic efficacy
The absence of pain for two pinprick tests in a row.
Measured: 5 min after injection
The width of the anesthetic field on the buccal side
maximal distance between the two painless needle's pricks on the buccal aspect of attached gingiva
Measured: 5 min after injection
The width of the anesthetic field on oral side
The maximal distance between the two painless needle's pricks on the oral aspect of the attached gingiva.
Measured: 5 min after injection
VASa
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
Measured: immediately after anesthetic administration
VASi
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
Measured: at the end of the treatment
VASp
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
Measured: one day follow-up
The duration
The duration of intervention, measured in minutes.
Measured: form start to finish od intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start22 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- 2 parallel groups, each with the experimental and the control group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasa Nikolic Jakoba, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212270
- Sponsor's protocol ID
- UBelgrade 36/8 (2)
- Status last verified
- May 2026
- First submitted
- 30 Sep 2025
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures
- ClinicalTrials.gov ID
- NCT07212270
- Acronym / sponsor ID
- UBelgrade 36/8 (2)
- Conditions
- Periodontitis, Gingivitis and Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 Oct 2025 (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 primary aim of this study is to evaluate the efficacy of intraseptal anesthesia using 0.3 mL of 4% articaine with 1:100,000 epinephrine (4% Ar+Ep) for periodontal flap surgery in patients with periodontitis and for gingivectomy/ gingivoplasty for the excision of hyperplastic gingival enlargements. The secondary aim is to compare clinical anesthetic parameters between the ISA and conventional anesthesia techniques.
Detailed description
In the test groups every patient is going to receive injections of 0.3 mL of 4% articaine with 1: 100,000 epinephrine (ORABLOC ® , 40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy), with a computer controlled anesthesia delivery system (Anaeject®, Septodont, Sallanches, France). In the control groups all surgical procedures is going to be performed under infiltration anesthesia, as commonly used in periodontal surgery. The success rate and the anesthetic field widths is going to be recorded by pinprick testing. The pain levels will be recorded using the Visual Analogue Scale (VAS) for the administration of anesthesia, during the surgical procedure and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- 2 parallel groups, each with the experimental and the control group
| Arm | Type | Receives |
|---|---|---|
| GG test | Experimental | Procedure: gingivectomy and gingivoplastyPatient subjected to gingivectomy and gingivoplasty interventions and anesthesia of choice is intraseptal anesthesia. |
| GG control | Active comparator | Procedure: gingivectomy and gingivoplastyPatient subjected to gingivectomy and gingivoplasty interventions under the local infiltration anesthesia. |
| PF test | Experimental | Procedure: periodontal flap surgeryPatients undergoing periodontal flap surgery under the intraseptal anesthesia. |
| PF control | Active comparator | Procedure: periodontal flap surgeryPatients undergoing periodontal flap surgery under the local infiltration anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years good systemic health
- gingivitis or periodontitis stage II and III
- at least 20 teeth present.
Key exclusion criteria (4 listed)
- allergy to 4%Ar+Ep
- pregnant or lactating females
- medication uptake and diseases affecting the periodontal tissues
- acute pain, swelling, and presence of gingival lesions.
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 |
|---|---|---|
| periodontal flap surgeryOpen flap debridement with intra-sulcular incisions or flaps with para-marginal incisions were performed by lifting the mucoperiosteal flap and debriding the periodontal defect under visual control. | Procedure or surgery | PF control, PF test |
| gingivectomy and gingivoplastysurgical methods for the excision of hyperplastically enlarged gingiva. | Procedure or surgery | GG control, GG test |
Primary outcome
The anesthetic efficacy
Time frame: 5 min after injection
The absence of pain for two pinprick tests in a row.
The width of the anesthetic field on the buccal side
Time frame: 5 min after injection
maximal distance between the two painless needle's pricks on the buccal aspect of attached gingiva
The width of the anesthetic field on oral side
Time frame: 5 min after injection
The maximal distance between the two painless needle's pricks on the oral aspect of the attached gingiva.
VASa
Time frame: immediately after anesthetic administration
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
VASi
Time frame: at the end of the treatment
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
VASp
Time frame: one day follow-up
The intensity of pain measured on 100mm Visual Analogue Scale, where 0 represented no pain and 100 the worst pain imaginable.
The duration
Time frame: form start to finish od intervention
The duration of intervention, measured in minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal flap surgery and gingivectomy and gingivoplasty in people with Periodontitis and Gingivitis and Periodontal Diseases, 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 3 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: under way, not looking for participants, as of the sponsor's last update on 5 May 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?
This study is still under way. Results are not available in the source record yet.
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?
The anesthetic efficacy (time frame: 5 min after injection). The study lists 7 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 5 May 2026.