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Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System (EISAAECCLAD)

Primary Purpose

Anesthesia, Local, Periodontitis

Status
Active
Phase
Locations
Serbia
Study Type
Observational
Intervention
scaling and root planing
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Anesthesia, Local focused on measuring intraseptal anesthesia, ISA, CCLADS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age ≥ 18 years
  • confirmed diagnosis of periodontitis
  • presence of minimum 20 teeth
  • absence of decay
  • preserved tooth vitality
  • good systematic health

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Arm Label

0.1 ml 4% articaine

0.2 ml 4% articaine

0.3 ml 4% articaine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of success anesthesia
The number of success anesthesia
Duration of soft tissue anesthesia
Time from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.
Width of the anesthetic field
Distance between two needles that were not causing pain on pinprick test, measured in millimeters.
Onset time for anesthesia
Time started after completion of the injection until profound anesthesia is establish, measured in seconds.
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.
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.
Presence of side effects
Record any side effects.
Analgesic medication consumption
Record number of analgesic medications.
Wich day analgesic medication is used
Wich day from intervention a analgesic medication is used

Secondary Outcome Measures

Pocket probing depths
Measuring the pocket probing depths by periodontal probe, in milimeteres.
Gingival margin level
Measuring the gingival margin level by periodontal probe, in milimeteres.
Clinical attachment level
Measuring the clinical attachment level by periodontal probe, measured in milimeters.
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.
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.

Full Information

First Posted
May 9, 2020
Last Updated
June 11, 2023
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT04392804
Brief Title
Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System
Acronym
EISAAECCLAD
Official Title
Efficacy of Intraseptal Anesthesia Obtained by 4 % Articaine With 1:100,000 Epinephrine Achieved by Computer-controlled Delivery System
Study Type
Observational

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Periodontitis
Keywords
intraseptal anesthesia, ISA, CCLADS

7. Study Design

Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.1 ml 4% articaine
Arm Description
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
Arm Title
0.2 ml 4% articaine
Arm Description
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
Arm Title
0.3 ml 4% articaine
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing
Intervention Description
one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution
Primary Outcome Measure Information:
Title
Number of success anesthesia
Description
The number of success anesthesia
Time Frame
1 day
Title
Duration of soft tissue anesthesia
Description
Time from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.
Time Frame
1 day
Title
Width of the anesthetic field
Description
Distance between two needles that were not causing pain on pinprick test, measured in millimeters.
Time Frame
1 day
Title
Onset time for anesthesia
Description
Time started after completion of the injection until profound anesthesia is establish, measured in seconds.
Time Frame
1 day
Title
Rate of pain during anesthetic delivery by VAS
Description
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.
Time Frame
1 day
Title
Rate of pain during scaling and root planing by VAS
Description
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.
Time Frame
1 day
Title
Presence of side effects
Description
Record any side effects.
Time Frame
1 day
Title
Analgesic medication consumption
Description
Record number of analgesic medications.
Time Frame
1 day
Title
Wich day analgesic medication is used
Description
Wich day from intervention a analgesic medication is used
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pocket probing depths
Description
Measuring the pocket probing depths by periodontal probe, in milimeteres.
Time Frame
1 day
Title
Gingival margin level
Description
Measuring the gingival margin level by periodontal probe, in milimeteres.
Time Frame
1 day
Title
Clinical attachment level
Description
Measuring the clinical attachment level by periodontal probe, measured in milimeters.
Time Frame
1 day
Title
Percentage of bleeding sites
Description
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.
Time Frame
1 day
Title
Percentage of plaque index
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age ≥ 18 years confirmed diagnosis of periodontitis presence of minimum 20 teeth absence of decay preserved tooth vitality good systematic health Exclusion Criteria: 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
Study Population Description
Systemically healthy periodontitis patients having the indication for scaling and root planing.
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no, for now, need to review conditions of terms of sharing the information

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Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System

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