Pulpal Blood Flow With the Use of Intra-nasal Anesthetic: a Randomized Double-blind Crossover Study
试验速览
- 阶段
- 4 期
- 入组人数
- 25
- 主要终点
- Change in Pulpal Blood Flow
研究概览
简要总结
Anesthetics with vasoconstrictors decrease pulpal blood flow but the impact of intranasal local anesthetics on blood flow is unknown. This blinded, randomized crossover clinical trial will compare the effects of different local anesthetics on anterior teeth in healthy volunteers. On separate study visits patients will receive either traditional injections or intranasal administration of the following solutions: 2% lidocaine with 1:100,000 epi, 3% mepivacaine, tetracaine HCl and oxymetazoline HCl, or saline. The following variables will be assessed: pulpal blood flow, pulpal sensibility, pain on administration, and adverse outcomes.
详细描述
Informed Consent Prior to screening, informed consent will be obtained from subjects by study personnel. All questions pertaining to the study will be addressed and answered prior to the participants' agreement to voluntarily partake. The informed consent explicitly states that participation, failure to participate, or withdrawal from the study will not impact the employment or educational standing or any student or employee.
Participants who are screened, selected, provided informed consent, and partake in the 6-week study will be compensated for their time commitment will receive a total of $100.00. They will receive $25 for the screening/impression visit if accepted and $25 for each of the additional 3 sessions.
Study Medications
2% Lidocaine with 1:100,000 epinephrine is the most commonly used local anesthetic in dentistry. It is associated in with a very small increase in blood pressure and heart rate due to the vasoconstrictor which is clinically insignificant in healthy adults. Reports of true allergy in the literature are very rare in a drug that has been administered millions a times a year for decades. This drug is associated with transient blood flow reduction to the pulp which is inconsequential to a healthy dental pulp but may have an impact on a tooth that has sustained dental injury.
3% mepivacaine is another commonly used local anesthetic. It has less inherent vasodilating properties than other local anesthetics and can be used without a vasoconstrictor. This drug has been shown to have a reduced impact on pulpal blood flow. However, 3% mepivacaine has a much shorter duration of action due to the lack of vasoconstrictor and may be of inadequate duration to manage a dental trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
the dentist who administered the study medications will know their identity but the participant, investigator who tests the teeth, and person calling for later outcomes will not know.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA 1 or 2 with no contraindications to the medications in this study
- •no restorations on the anterior teeth, no sign of history of dental trauma, and a normal periodontium to be included
排除标准
- •known hypersensitivity to tetracaine, benzyl alcohol ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, lidocaine, and mepivacaine -inadequately controlled hypertension or thyroid disease, frequent nose bleeds, or history of methemoglobinemia will not be eligible. Patients taking monoamine oxidase inhibitors are not eligible as well. Pregnant women will not be eligible as a precaution.
- •Subjects will be excluded if they have restorations, traumatic occlusion, orthodontic appliance, pathologic discoloration of dentition, fixed retainer on maxillary anterior, resorption, pulp canal obliteration, previous endodontic therapy, history of trauma to maxillary anterior dentition, or a fractured tooth structure
研究组 & 干预措施
Sequence 1
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 1 participants will receive the drugs in the following sequence: 1) tetracaine HCl and oxymetazoline HCl 2) 3% mepivacaine 3) 2% lidocaine with 1:100,000 epi
干预措施: tetracaine HCl and oxymetazoline HCL (Drug)
Sequence 1
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 1 participants will receive the drugs in the following sequence: 1) tetracaine HCl and oxymetazoline HCl 2) 3% mepivacaine 3) 2% lidocaine with 1:100,000 epi
干预措施: saline intranasal (Drug)
Sequence 1
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 1 participants will receive the drugs in the following sequence: 1) tetracaine HCl and oxymetazoline HCl 2) 3% mepivacaine 3) 2% lidocaine with 1:100,000 epi
干预措施: saline infiltration (Drug)
Sequence 2
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 2 participant will receive the drugs in the following sequence: 1) 2% lidocaine with 1:100,000 epi 2) tetracaine HCl and oxymetazoline HCl 3) 3% mepivacaine
干预措施: tetracaine HCl and oxymetazoline HCL (Drug)
Sequence 2
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 2 participant will receive the drugs in the following sequence: 1) 2% lidocaine with 1:100,000 epi 2) tetracaine HCl and oxymetazoline HCl 3) 3% mepivacaine
干预措施: saline intranasal (Drug)
Sequence 2
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 2 participant will receive the drugs in the following sequence: 1) 2% lidocaine with 1:100,000 epi 2) tetracaine HCl and oxymetazoline HCl 3) 3% mepivacaine
干预措施: saline infiltration (Drug)
Sequence 3
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 3 participants will receive the drugs in the following sequence: 1) 3% mepivacaine 2) 2% lidocaine with 1:100,000 epi 3) tetracaine HCl and oxymetazoline HCl
干预措施: tetracaine HCl and oxymetazoline HCL (Drug)
Sequence 3
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 3 participants will receive the drugs in the following sequence: 1) 3% mepivacaine 2) 2% lidocaine with 1:100,000 epi 3) tetracaine HCl and oxymetazoline HCl
干预措施: saline intranasal (Drug)
Sequence 3
All participants will be exposed to all study medications during 3 subsequent visits with a 1 week washout between visits.
Sequence 3 participants will receive the drugs in the following sequence: 1) 3% mepivacaine 2) 2% lidocaine with 1:100,000 epi 3) tetracaine HCl and oxymetazoline HCl
干预措施: saline infiltration (Drug)
结局指标
主要结局
Change in Pulpal Blood Flow
时间窗: baseline and 7, 12, 17, 32, 47, and 62 minutes after administration of anesthetics
change in pulpal blood flow will be measured using doppler flowmetry
次要结局
- Pulp sensibility(60 minutes after administration of anesthetics)
- Pain(24 hours after administration of local anesthetics)
- adverse outcomes(immediately after administration of local anesthetics)
- Adverse outcomes(24 hours after administration of local anesthetics)
研究者
Janice Townsend
Associate Professor
Louisiana State University Health Sciences Center in New Orleans