Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VASa
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Periodontist do not know the type of anesthesia given by the investigator
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years good systemic health
- •gingivitis or periodontitis stage II and III
- •at least 20 teeth present.
排除标准
- •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.
研究组 & 干预措施
GG test
Patient subjected to gingivectomy and gingivoplasty interventions and anesthesia of choice is intraseptal anesthesia.
干预措施: gingivectomy and gingivoplasty (Procedure)
GG control
Patient subjected to gingivectomy and gingivoplasty interventions under the local infiltration anesthesia.
干预措施: gingivectomy and gingivoplasty (Procedure)
PF test
Patients undergoing periodontal flap surgery under the intraseptal anesthesia.
干预措施: periodontal flap surgery (Procedure)
PF control
Patients undergoing periodontal flap surgery under the local infiltration anesthesia.
干预措施: periodontal flap surgery (Procedure)
结局指标
主要结局
VASa
时间窗: 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
时间窗: 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
时间窗: 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.
width of the anesthetic field on oral side
时间窗: 5 min after injection
maximal distance between the two painless needle's pricks on the oral aspect of attached gingiva
VASa
时间窗: immediately after anesthetic administration
intensity of pain measured on 100mm VAS scale
VASi
时间窗: at the end of the treatment
intensity of pain measured on 100mm VAS scale
VASp
时间窗: one day follow-up
intensity of pain measured on 100mm VAS scale
duration
时间窗: form start to finish od intervention
duration of intervention
The anesthetic efficacy
时间窗: 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
时间窗: 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
时间窗: 5 min after injection
The maximal distance between the two painless needle's pricks on the oral aspect of the attached gingiva.
The duration
时间窗: form start to finish od intervention
The duration of intervention, measured in minutes.
次要结局
未报告次要终点
研究者
Natasa Nikolic Jakoba
professor
University of Belgrade