Anesthesia, LocalEISAAECCLADNCT04392804
Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System
An observational study of Anesthesia, Local and Periodontitis, run by University of Belgrade at 1 site in Serbia.
Trial summary
The aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (ISA), achieved by computer-controlled local anesthetic delivery system CCLADS, for scaling and root planing, as a primary outcome of the study. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Periodontitis
- What is being tested?
- scaling and root planing
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteSerbia
- Study dates
- 19 May 2020to 30 Dec 2023
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Systemically healthy periodontitis patients having the indication for scaling and root planing.
Who may be able to join
- age ≥ 18 years
- confirmed diagnosis of periodontitis
- presence of minimum 20 teeth
- absence of decay
- preserved tooth vitality
- good systematic health
Who cannot join
- allergy to articaine with 1: 100,000 epinephrine
- pregnancy
- lactation
- medication uptake that affects the periodontal supporting tissues
- acute pain, swelling, 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
Official title: Efficacy of Intraseptal Anesthesia Obtained by 4 % Articaine With 1:100,000 Epinephrine Achieved by Computer-controlled Delivery System
The aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (ISA), achieved by computer-controlled local anesthetic delivery system CCLADS, for scaling and root planing, as a primary outcome of the study. In addition, as secondary outcome of the study the impact of destruction of the periodontal supporting tissues on clinical anesthetic parameters of the ISA achieved by 4% articaine with 1:100,000 epinephrine, using CCLAD system.
Read the detailed description
After including the patients into the study, patient needs to sign a written consent. After that, the next appointment will be scheduled. On the next appointment, each patient included in this study will undergo ultrasound cleaning and receive guidance for adequate everyday oral hygiene. The next appointment, after 10 days will be scaling and root planing for selected periodontal pockets. Because it is painful treatment, anesthesia is needed to be administrated. Patients will be split into three groups by picking cards, for receiving different doses of 4% articaine with 1:100,000 epinephrine ORABLOC® (40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy) in each group. Doses will be 0.1 ml, 0.2 ml, and 0.3 ml of 4% articaine with epinephrine for one appointment scaling and root planing. Anesthesia will be obtained by CCLADS device Anaject® (Septodont, Sallanches, Franc). The Intraseptal anesthesia (ISA) will be the method of administrating the anesthesia. Parameters of the device will be a mode with constant pressure, injection speed - mode LOW 0.005 ml/s. Time for application will depend on the dose, and it will be 20 s for 0.1 ml, 40 s for 0.2 ml, and 60 s for 0.3 ml.
Parameters of local anesthesia will be recorded by the pin-prick test. The pain will be rated by the visual-analogue scale (VAS). The pain will be rated immediately upon termination of the local anesthetic delivery and during the scaling and root planing.
Patients will be followed up the next day for local side effects and their need for analgesic medication.
- Conditions
- Anesthesia, Local, Periodontitis
- Being tested
- scaling and root planing
- Keywords
- intraseptal anesthesia, ISA, CCLADS
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingProcedure or surgery
one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution
| Study group | Role | What they receive |
|---|---|---|
| 0.1 ml 4% articaine | single dose of 0.1 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing Receives: Procedure: scaling and root planing | |
| 0.2 ml 4% articaine | single dose of 0.2 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing Receives: Procedure: scaling and root planing | |
| 0.3 ml 4% articaine | single dose of 0.3 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing Receives: Procedure: scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of success anesthesia
The number of success anesthesia
Measured: 1 day
Duration of soft tissue anesthesia
Time from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.
Measured: 1 day
Width of the anesthetic field
Distance between two needles that were not causing pain on pinprick test, measured in millimeters.
Measured: 1 day
Onset time for anesthesia
Time started after completion of the injection until profound anesthesia is establish, measured in seconds.
Measured: 1 day
Rate of pain during anesthetic delivery by VAS
Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is labeled for the minimum feel of pain or no pain, and 100 is labeled for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.
Measured: 1 day
Rate of pain during scaling and root planing by VAS
Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is score for the minimum feel of pain or no pain, and 100 is score for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.
Measured: 1 day
Presence of side effects
Record any side effects.
Measured: 1 day
Analgesic medication consumption
Record number of analgesic medications.
Measured: 1 day
Wich day analgesic medication is used
Wich day from intervention a analgesic medication is used
Measured: 7 days
Secondary outcomes (5)
Pocket probing depths
Measuring the pocket probing depths by periodontal probe, in milimeteres.
Measured: 1 day
Gingival margin level
Measuring the gingival margin level by periodontal probe, in milimeteres.
Measured: 1 day
Clinical attachment level
Measuring the clinical attachment level by periodontal probe, measured in milimeters.
Measured: 1 day
Percentage of bleeding sites
The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage.
Measured: 1 day
Percentage of plaque index
The number of sites where plaque is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the plaque index as a percentage.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start19 May 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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
- Observational
- Enrolment
- 360 participants (actual)
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
- NCT04392804
- Sponsor's protocol ID
- UBelgrade 36/8
- Acronym
- EISAAECCLAD
- Status last verified
- Jun 2023
- First submitted
- 9 May 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no, for now, need to review conditions of terms of sharing the information
Publications
Djoric J, Djinic Krasavcevic A, Barac M, Kuzmanovic Pficer J, Brkovic B, Nikolic-Jakoba N. Patient discomfort and intensity of intraseptal anesthesia of computer-controlled articaine/epinephrine delivery for scaling and root planing. Clin Oral Investig. 2023 Oct;27(10):6221-6234. doi: 10.1007/s00784-023-05238-1. Epub 2023 Aug 29.
PubMed 37644233Djoric J, Djinic Krasavcevic A, Barac M, Kuzmanovic Pficer J, Brkovic B, Nikolic-Jakoba N. Efficacy of intraseptal anesthesia obtained by computer-controlled articaine with epinephrine delivery in scaling and root planing. Clin Oral Investig. 2023 Jun;27(6):2913-2922. doi: 10.1007/s00784-023-04889-4. Epub 2023 Feb 6.
PubMed 36746819
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraseptal Anesthesia Obtained by 4 % Articaine With 1:100,000 Epinephrine Achieved by Computer-controlled Delivery System
- ClinicalTrials.gov ID
- NCT04392804
- Acronym / sponsor ID
- EISAAECCLAD / UBelgrade 36/8
- Conditions
- Anesthesia, Local, Periodontitis
- Keywords
- intraseptal anesthesia, ISA, CCLADS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 19 May 2020 (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 aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (ISA), achieved by computer-controlled local anesthetic delivery system CCLADS, for scaling and root planing, as a primary outcome of the study. In addition, as secondary outcome of the study the impact of destruction of the periodontal supporting tissues on clinical anesthetic parameters of the ISA achieved by 4% articaine with 1:100,000 epinephrine, using CCLAD system.
Detailed description
After including the patients into the study, patient needs to sign a written consent. After that, the next appointment will be scheduled. On the next appointment, each patient included in this study will undergo ultrasound cleaning and receive guidance for adequate everyday oral hygiene. The next appointment, after 10 days will be scaling and root planing for selected periodontal pockets. Because it is painful treatment, anesthesia is needed to be administrated. Patients will be split into three groups by picking cards, for receiving different doses of 4% articaine with 1:100,000 epinephrine ORABLOC® (40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy) in each group. Doses will be 0.1 ml, 0.2 ml, and 0.3 ml of 4% articaine with epinephrine for one appointment scaling and root planing. Anesthesia will be obtained by CCLADS device Anaject® (Septodont, Sallanches, Franc). The Intraseptal anesthesia (ISA) will be the method of administrating the anesthesia. Parameters of the device will be a mode with constant pressure, injection speed - mode LOW 0.005 ml/s. Time for application will depend on the dose, and it will be 20 s for 0.1 ml, 40 s for 0.2 ml, and 60 s for 0.3 ml.
Parameters of local anesthesia will be recorded by the pin-prick test. The pain will be rated by the visual-analogue scale (VAS). The pain will be rated immediately upon termination of the local anesthetic delivery and during the scaling and root planing.
Patients will be followed up the next day for local side effects and their need for analgesic medication.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.1 ml 4% articaine | – | Procedure: scaling and root planingsingle dose of 0.1 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing |
| 0.2 ml 4% articaine | – | Procedure: scaling and root planingsingle dose of 0.2 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing |
| 0.3 ml 4% articaine | – | Procedure: scaling and root planingsingle dose of 0.3 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Systemically healthy periodontitis patients having the indication for scaling and root planing.
Key inclusion criteria (6 listed)
- age ≥ 18 years
- confirmed diagnosis of periodontitis
- presence of minimum 20 teeth
- absence of decay
- preserved tooth vitality
Key exclusion criteria (5 listed)
- allergy to articaine with 1: 100,000 epinephrine
- pregnancy
- lactation
- medication uptake that affects the periodontal supporting tissues
- acute pain, swelling, 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 |
|---|---|---|
| scaling and root planingone appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution | Procedure or surgery | 0.1 ml 4% articaine, 0.2 ml 4% articaine, 0.3 ml 4% articaine |
Primary outcome
Number of success anesthesia
Time frame: 1 day
The number of success anesthesia
Duration of soft tissue anesthesia
Time frame: 1 day
Time from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.
Width of the anesthetic field
Time frame: 1 day
Distance between two needles that were not causing pain on pinprick test, measured in millimeters.
Onset time for anesthesia
Time frame: 1 day
Time started after completion of the injection until profound anesthesia is establish, measured in seconds.
Rate of pain during anesthetic delivery by VAS
Time frame: 1 day
Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is labeled for the minimum feel of pain or no pain, and 100 is labeled for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.
Rate of pain during scaling and root planing by VAS
Time frame: 1 day
Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is score for the minimum feel of pain or no pain, and 100 is score for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.
Presence of side effects
Time frame: 1 day
Record any side effects.
Analgesic medication consumption
Time frame: 1 day
Record number of analgesic medications.
Wich day analgesic medication is used
Time frame: 7 days
Wich day from intervention a analgesic medication is used
5 secondary outcomes
Pocket probing depths
Time frame: 1 day
Gingival margin level
Time frame: 1 day
Clinical attachment level
Time frame: 1 day
Percentage of bleeding sites
Time frame: 1 day
Percentage of plaque index
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 37644233Djoric J, Djinic Krasavcevic A, Barac M, Kuzmanovic Pficer J, Brkovic B, Nikolic-Jakoba N. Patient discomfort and intensity of intraseptal anesthesia of computer-controlled articaine/epinephrine delivery for scaling and root planing. Clin Oral Investig. 2023 Oct;27(10):6221-6234. doi: 10.1007/s00784-023-05238-1. Epub 2023 Aug 29.
- Derived from this study: PubMed 36746819Djoric J, Djinic Krasavcevic A, Barac M, Kuzmanovic Pficer J, Brkovic B, Nikolic-Jakoba N. Efficacy of intraseptal anesthesia obtained by computer-controlled articaine with epinephrine delivery in scaling and root planing. Clin Oral Investig. 2023 Jun;27(6):2913-2922. doi: 10.1007/s00784-023-04889-4. Epub 2023 Feb 6.
- Individual participant dataSharing planned: No. no, for now, need to review conditions of terms of sharing the information
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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?
An observational study of Anesthesia, Local and Periodontitis, 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Jun 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?
Results are not available in the source record.
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?
Number of success anesthesia (time frame: 1 day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392804, which also lists 2 linked publications.
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 15 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.