Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia
研究概览
简要总结
The purpose of this study is to determine whether a combination of anesthetics (numbing medicine) will adequately anesthetize teeth over a different combination. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.
详细描述
60 human subjects with Symptomatic Irreversible Pulpitis (SIP) in mandibular molars will be randomly allocated into 2 groups. One group will receive a combination of: 1 cartridge of buffered 2% lidocaine w/ 1:100k epi via inferior alveolar nerve block (IANB) followed by 1 cartridge of 3% mepivacaine via IANB. This will be followed by 0.5 cartridges (0.9mL) of buffered 4% articaine with 1:100k epi via buccal infiltration and 0.5 cartridges of buffered 4% articaine with 1:100k epi via lingual infiltration. All IANB injections will include a lingual block. The second group will be provided an unbuffered version of the same combination. An electronic pulp tester (EPT) will be used to determine the vitality of the treated tooth. Endodontic treatment will be initiated after two consecutive EPT readings of 80, displaying pulpal anesthesia. Profound pulpal anesthesia is described by the patient's report on the visual analog scale after the pulpotomy.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
A statistician will provide a two-product randomization scheme which will randomize each of the 60 subjects on the order of their entry into the study. The research assistants will be aware of and document this scheme, but the student researcher/PI will not know what type of anesthetic will be administered.
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
- 是
入选标准
- •Be between the ages of 18 and 80 years old
- •Have the ability and willingness to independently consent to treatment and study participation
- •Have an uncomplicated medical history (ASA I and II)
- •Not be pregnant
- •Have no allergies local anesthetics/sulfites (confirmed or self-reported)
- •Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours)
- •Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data
- •Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study
排除标准
- •A negative response to cold in the proposed treatment tooth
- •A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling
研究组 & 干预措施
Buffered
Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
干预措施: Mepivacaine plain (Drug)
Buffered
Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
干预措施: Lidocaine w/ epi (Drug)
Unbuffered
Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics
干预措施: Lidocaine w/ epi (Drug)
Unbuffered
Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics
干预措施: Mepivacaine plain (Drug)
Unbuffered
Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics
干预措施: Articaine w/ epi (Drug)
Buffered
Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
干预措施: Articaine w/ epi (Drug)
Buffered
Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
干预措施: Sodium bicarbonate (Drug)
结局指标
主要结局
Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia
时间窗: Up to 20 minutes post-drug administration
Patient will report their comfort during treatment based on a visual analogue scale (VAS) graphic. Visual analog scale (VAS) is based on a scale of 0-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment indicating there was inadequate anesthesia. A VAS score of 0 indicates no pain.
次要结局
- Median Time to Profound Pulpal Anesthesia(Up to 15 minutes post-drug administration)
研究者
Kenneth J. Spolnik DDS
Department of Endodontics Chair
Indiana University