Evaluation of efficacy of buccal infiltration anesthesia with 4% articaine for orthodontic extraction of mandibular premolars: a placebo controlled split mouth study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.To assess the amount of pain perceived on Visual Analogue Scale of 10cm length (VAS-10).
研究概览
简要总结
1. Patients who fulfil inclusion criteria will be selected
2. The study design will be discussed with every selected subject
3. Informed written consent will be obtained
4. Patients will be seated on the dental chair and explained about VAS and verbal satisfaction score & pinprick score before starting the procedure
5. All the extractions will be done by single surgeon
6. Each patient will be asked to rinse the oral cavity with chlorhexidine mouthwash(0.2%) for 30 seconds
7. Under aseptic conditions, peri-oral area will be scrubbed using 5% povidine iodine solution and patient will be draped with sterile sheets
8. Injection site will be cleaned with sterile gauze
9. A 27gauge needle attached to dental syringe and cartridge will be used for buccal infiltration. To deliver lingual infiltration a sterile disposable insulin syringe will be used
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Patients under the study: Group I- will receive buccal infiltration of 1.8 ml 4% articaine with 1:100000 epinephrine plus lingual infiltration of 0.4 ml 4% articaine and Group II- will receive buccal infiltration of 1.8 ml 4% articaine with 1:100000 epinephrine plus lingual infiltration of 0.4 ml normal saline (placebo).
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Patient will be informed to report the numbness of lip as soon as they feel
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After 5 minutes the buccal and lingual gingiva will be examined using a pinprick test (with probe). Lingual anesthesia will be assessed on 5-score verbal scale. Whenever pain experienced by the patient will be reported as "obviate" (score 2) or more, it will be considered as a failure of the buccal infiltration and additional infiltration of articaine will be given lingually and we will wait for additional 5 minutes before continuing the procedure
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Intra-alveolar (forceps) technique will be used for the extraction after routine tooth luxation by dental elevator
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Care will be taken to ensure minimal trauma to the surrounding tissue
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Pain will be assessed on VAS during extraction
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Patients will be asked to rate the degree of their satisfaction on the verbal scale after extraction
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Time taken to complete the procedure will be recorded
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Post operative instructions will be given and analgesic will be prescribed
The values will be tabulated and results will be derived
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group of 15 to 25 2.Patients who want extraction of both left and right mandibular premolars 3.Patients belonging to ASA class I and II 4.Patients who grant consent to be a part of the study.
排除标准
- •History of allergy to local anesthetic agents
- •History of uncontrolled diabetes mellitus, hypertension, or renal diseases
- •Patients on central nervous system depressants including alcohol or any analgesic medication within the last 48 hours
- •Pregnant and lactating females
- •Patients having abscess or any other lesion at the injection site.
结局指标
主要结局
1.To assess the amount of pain perceived on Visual Analogue Scale of 10cm length (VAS-10).
时间窗: 5 minutes after giving anesthetic, during extraction of tooth.
2.To assess the profoundness of lingual anesthesia: It will be determined by degree of sensibility of lingual mucosa to pin prick test on a 5-score verbal scale
时间窗: 5 minutes after giving anesthetic, during extraction of tooth.
次要结局
- Time taken for extraction and patient satisfaction(just after completion of procedure)