Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System
- Conditions
- PeriodontitisAnesthesia, Local
- Interventions
- Procedure: scaling and root planing
- Registration Number
- NCT04392804
- Lead Sponsor
- University of Belgrade
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 360
- age ≥ 18 years
- confirmed diagnosis of periodontitis
- presence of minimum 20 teeth
- absence of decay
- preserved tooth vitality
- good systematic health
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 0.2 ml 4% articaine 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 0.3 ml 4% articaine 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 0.1 ml 4% articaine scaling and root planing 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
- Primary Outcome Measures
Name Time Method Presence of side effects 1 day Record any side effects.
Number of success anesthesia 1 day The number of success anesthesia
Duration of soft tissue anesthesia 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 1 day Distance between two needles that were not causing pain on pinprick test, measured in millimeters.
Onset time for anesthesia 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 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 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.
Wich day analgesic medication is used 7 days Wich day from intervention a analgesic medication is used
Analgesic medication consumption 1 day Record number of analgesic medications.
- Secondary Outcome Measures
Name Time Method Clinical attachment level 1 day Measuring the clinical attachment level by periodontal probe, measured in milimeters.
Percentage of plaque index 1 day 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.
Pocket probing depths 1 day Measuring the pocket probing depths by periodontal probe, in milimeteres.
Gingival margin level 1 day Measuring the gingival margin level by periodontal probe, in milimeteres.
Percentage of bleeding sites 1 day 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.
Trial Locations
- Locations (1)
Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
🇷🇸Belgrade, Serbia