Patient Perception Between Two Emergency Treatments of Symptomatic Irreversible Pulpitis. A Randomized Multicenter Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Patients´ pain perception
研究概览
简要总结
To evaluate in a comparative way the perception of the patient who comes with pain due to irreversible pulpitis in a tooth and who receives two types of treatment: complete pulpectomy (or control group) or pulpotomy (or experimental group).
Prospective randomized and multicenter study. It will be carried out in 4 centers of similar socio-professional characteristics, with the same operative protocol. On a significant sample of emergency patients with a concrete clinical manifestation of symptomatic irreversible pulpitis, one type of intervention or another will be performed randomly. The data will be collected by means of a visual numeric scale (NRS).
The null hypothesis is that both interventions provide the same reduction of pain in patients who present symptomatic irreversible pulpitis.
All the patients who come to one of the private centers with irreversible pulpitis and who meet the defined criteria for inclusion and exclusion will be selected.
The type of procedure that will be performed in the control group will be the complete removal of the pulp by means of a defined instrumentation technique, also called Pulpectomy. The procedure to be performed in the experimental group will be the removal of the pulp only at coronal level, also called Pulpotomy. The interventions will be assigned randomly and the "List Randomizer" (random.org) will be used for the randomization.
详细描述
Clinical procedure will be the same in both groups with regard to the anesthetic technique, and the cavity access and provisional closure of the aperture. The characteristics of both interventions will be described in detail in order to homogenize the procedures. The patient will be conveniently informed before requesting his/her Informed Consent for his/her voluntary participation in the study. Their identification data will be treated in accordance with the provisions of Regulation (EU) 2016/679 of the European Parliament and Council of April 27, 2016, and the Organic Law 3/2018 of 5/12, currently in force, will remain in custody at the Center where they receive treatment and will not be shared by the other centers of the study.
The patient will not be aware of the type of procedure he has been assigned for and will express in a numerical scale according to his perception of the pain on 4 occasions: before starting treatment, at 8-12, 24 and 72 hours after treatment. Likewise, right after receiving the treatment, he will answer some questions related to the degree of comfort during the treatment and about his perception of the time of the intervention.
Data sheets will be collected and treated statistically.
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 (Participant)
盲法说明
The patient will not be aware of the type of procedure he has been assigned for.
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient in American Society of Anesthesiologists I or II condition.
- •Patient who comes to the emergency room with irreversible pulpitis in a single tooth.
- •Patients of age >20 years.
- •Positive response to the vitality test and bleeding after pulp exposure.
排除标准
- •American Society of Anesthesiologists patients>II.
- •Pharmacological allergies that contraindicate the intervention.
- •Teeth with negative vitality test and no bleeding after pulp exposure.
- •Signs of concomitant periodontal infection such as swelling or fistula.
- •Teeth with immature roots.
- •Patients who are medicated with anxiolytics.
- •Abuse of psychotropic drugs or medication that may alter the perception of pain 15 days before the intervention.
- •Pregnant or breast-feeding women.
- •Interventions with conscious sedation.
- •Pathological mental state (dementia, psychosis).
- •Lack of collaboration or non-acceptance of the consent of the study.
结局指标
主要结局
Patients´ pain perception
时间窗: Through study completion, an average of 1 year.
The patient's perception of the degree of post-operative pain following emergency treatment
次要结局
- Procedure time(Through study completion, an average of 1 year.)
研究者
Guillem Esteve-Pardo
DDS
Aula Dental Avanzada