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临床试验/NCT04392804
NCT04392804进行中(未招募)不适用

Efficacy of Intraseptal Anesthesia Obtained by 4 % Articaine With 1:100,000 Epinephrine Achieved by Computer-controlled Delivery System

University of Belgrade1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2020年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
360
试验地点
1
主要终点
Presence of side effects

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Presence of side effects

时间窗: 1 day

Record any side effects.

Width of the anesthetic field

时间窗: 1 day

Distance between two needles that were not causing pain on pinprick test, measured in millimeters.

Number of success anesthesia

时间窗: 1 day

The number of success anesthesia

Duration of soft tissue anesthesia

时间窗: 1 day

Time from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.

Onset time for anesthesia

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 7 days

Wich day from intervention a analgesic medication is used

Analgesic medication consumption

时间窗: 1 day

Record number of analgesic medications.

次要结局

  • Clinical attachment level(1 day)
  • Percentage of plaque index(1 day)
  • Pocket probing depths(1 day)
  • Gingival margin level(1 day)
  • Percentage of bleeding sites(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasa Nikolic Jakoba

Associate professor, DDS, MSc, PhD

University of Belgrade

研究点 (1)

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