跳至主要内容
临床试验/CTRI/2024/05/067798
CTRI/2024/05/067798招募中4 期

Comparison of anesthetic efficacy of 4 percent articaine with epinephrine in the ratio of 1 to 100000 as buccal infiltration and 2 percent lignocaine with epinephrine in the ratio of 1 to 80000 as inferior alveolar nerve block in patients with irreversible pulpitis A randomized clinical trial

Guru Nanak Institute of Dental Sciences and Research1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
22
试验地点
1
主要终点
1.To compare the onset of anesthesia using 4% articaine with 1:100,000 epinephrine as buccal infiltration & 2% Lignocaine with 1:80,000 epinephrine as inferior alveolar nerve block.

研究概览

简要总结

AIM OF THE STUDY: To compare onset,duration and anesthetic efficacy of 4% Articaine with 1:100,000 epinephrine buccal infiltration and  2% lignocaine with 1:80,000 epinephrine  inferior alveolar nerve block in patients with irreversible pulpitis

MATERIALS AND METHODS: The study is designed as a prospective, randomized, double blinded, clinical trial. 22  patients will be enrolled from the Department of Conservative Dentistry and Endodontics who are systemically healthy[ASA I & II) between 18-45 years of age and fulfilling the inclusion criteria of the study. Patient will be randomly assigned into two equal groups using Simple Random Sampling sequentially.Odd number will be assigned to Group 1 (1,3,5) and even number will be assigned to Group 2 (2,4,6).

Group I (n=11)Buccal infiltration using standard cartridges of 4 % articaine with 1:100000 epinephrine

Group II(n=11) Inferior alveolar nerve block  using standardized cartridges of 2% lignocaine with 1:80000 epinephrine

Patient and outcome assessor will be blinded to the groups of the study. The randomized order of instrumentation procedure will be enclosed in sealed, opaque envelopes. Treatment will be carried out in single visit. Root canal treatment will be performed after administration of these two type of anesthetic agents and mode of administration.  Each of the 22 patients, will be taught how to use Heft Parker Pain assessment  scale. . Pain will be evaluated at following time intervals: Just before administration of anesthetic agents,during the endodontic procedure,immediate after obturation and 6 & 12 hr  after completion of the procedure.Onset and duration of two types of anesthetic agents will be evaluated with the help of a digital stop watch.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with irreversible pulpitis 2.Permanent mandibular 1st molar 3.Tooth with closed apex 4.Teeth with sound periodontal apparatus 5.Only healthy individual(ASA I or II).

排除标准

  • 1.Patients allergic to amide local anesthetics 2.Non vital teeth 3.Patients taking antibiotics and/or analgesic in last 5 days 4.Retreatment cases 5.Teeth with calcified canals Pregnant and lactating women.

结局指标

主要结局

1.To compare the onset of anesthesia using 4% articaine with 1:100,000 epinephrine as buccal infiltration & 2% Lignocaine with 1:80,000 epinephrine as inferior alveolar nerve block.

时间窗: 1.Onset of anesthesia:-Time lapse between the end of the anesthesia given and onset of symptoms of subjective anesthesia | 2.Duration of anesthesia:It will be calculated by recording the time of onset of anesthesia and patient reporting the loss of numbness by thorough conversation with patient over telephone 1hr ,2hr,3 hr,4 hr immediately after obturation | 3.Pain asessment :Pre-operative,During the operative procedure and 6 & 12 hr after completion of the endodontic procedure

2. To compare the duration of anesthesia using 4% articaine with 1:100,000 epinephrine as buccal infiltration & 2% Lignocaine with 1:80,000 epinephrine as inferior alveolar nerve block

时间窗: 1.Onset of anesthesia:-Time lapse between the end of the anesthesia given and onset of symptoms of subjective anesthesia | 2.Duration of anesthesia:It will be calculated by recording the time of onset of anesthesia and patient reporting the loss of numbness by thorough conversation with patient over telephone 1hr ,2hr,3 hr,4 hr immediately after obturation | 3.Pain asessment :Pre-operative,During the operative procedure and 6 & 12 hr after completion of the endodontic procedure

3. To compare the effectiveness of anesthesia (pain assessment) using Heft Parker scale using 4% articaine with 1:100,000 epinephrine & 2% Lignocaine with 1:80,000 as inferior alveolar nerve block

时间窗: 1.Onset of anesthesia:-Time lapse between the end of the anesthesia given and onset of symptoms of subjective anesthesia | 2.Duration of anesthesia:It will be calculated by recording the time of onset of anesthesia and patient reporting the loss of numbness by thorough conversation with patient over telephone 1hr ,2hr,3 hr,4 hr immediately after obturation | 3.Pain asessment :Pre-operative,During the operative procedure and 6 & 12 hr after completion of the endodontic procedure

次要结局

  • Retrospective analysis of CBCT Scan to determine cause-effect relationship of the clinical outcome[Bone width,position of the apical foramen]

研究者

发起方
Guru Nanak Institute of Dental Sciences and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

ABHIJIT GHOSH

Guru Nanak Institute of Dental Sciences and Research

研究点 (1)

Loading locations...

相似试验