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临床试验/NCT06779448
NCT06779448已完成不适用

The Effect of Rubber Dam on Objective and Subjective Parameters of Stress During Dental Treatment in Children

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
blood pressure

研究概览

简要总结

Although rubber dam application provides many advantages, several pediatric dentists avoid using it, arguing that it may increase stress for young patients.

The purpose of this clinical study was to evaluate the effect of rubber dam on the subjective and objective stress in children and the effects of preferred anesthesia methods during use of the rubber dam on the same parameters.

A total of 100 children, aged 6-12 years old participated in this study. The selected site of the patients divided cotton roll and rubber dam application group, and the rubber dam group divided also two subgroups as topical and infiltration anesthesia application. Objective parameters of stress of the patients and pulse rate of the operator were measured at three different time points. Pain perception was also evaluated subjectively. The data were statistically analyzed (p<0.05).

详细描述

This randomized, controlled, single-blinded study included 100 healthy, cooperative children (Frankl Scale, Rating 3-4) aged 6-12 years, classified as ASA I (american assossiation of anesthesiologist), with bilateral fully erupted mandibular first permanent molars requiring pit and fissure sealant procedures. The inclusion criteria were based on the International Caries Detection and Assessment System II, including deep and retentive pits and fissures, no restorations, and no evidence of carious lesions.

The study was planned as split mouth design: For each patient, one tooth was selected for rubber dam isolation, while the corresponding tooth from the opposite quadrant was chosen for cotton roll isolation. The Rubber dam application group divided also into two groups as topical EMLA application, and infiltration anesthesia application. Randomization was performed using manually generated sealed envelopes containing information about which isolation method and anesthesia technique would be used on which side of the jaw (right or left). Random numbers were written on separate papers, folded, and placed in opaque sealed envelopes. Each participant chose an envelope and was assigned the printed participant number. Each number identified the teeth included in the study, the isolation technique specified for each tooth, and the anesthesia method to be used during the rubber dam application. Objective stress parameters (pulse rate, systolic blood pressure and diastolic blood pressure) for the children and the pulse rate of the operator were recorded at three different points: immediately after sitting in the treatment chair and prior to the beginning of the treatment (T1), after light curing of the fissure sealant with cotton roll isolation (T2), and following the completion of treatment and removal of the cotton rolls. Systolic and diastolic blood pressure were measured using an automatic blood pressure monitor (OMRON M2, Omron Healthcare Co., Kyoto, Japan). Pulse rate was evaluated with a fingertip pulse oximeter (LYG88 Pulse Oximeter, China). The operator's pulse rate was also recorded. Pain perception was assessed subjectively post-procedure using the Wong-Baker FACES Pain Rating Scale (WBFPRS) and Visual Analogue Scale (VAS). One week later, the patient was invited to a second appointment for the treatment of the corresponding tooth from the opposite side. At this stage, the teeth were cleaned like in cotton roll group, and the patients were divided into two groups according to the randomization procedure: topical anesthesia and infiltrative anesthesia before the placement of the clamp. The topical anesthetic agent (EMLA, AstraZeneca, Cotia, São Paulo, Brazil) was applied using a disposable dental Q-tip for 10-20 seconds and infiltration anesthesia (Maxicaine Forte, Artikain, VEM Drug, Turkey) was performed with a 20-gauge needle. Following the administration of anesthetics, an appropriate size rubber dam and metal clamp was placed in the mandibular arch, and pit and fissure sealant was applied to the opposite arch. The stress parameters of the subjects were recorded at three measurement points. At the conclusion of the treatment, pain perception was evaluated subjectively using the WBFPRS and VAS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •6-12 years child,
  • •classified as ASA I (american assossiation of anesthesiologist)
  • •cooperative children
  • •child with bilateral fully erupted mandibular first permanent molars requiring pit and fissure sealant procedures.

排除标准

  • •patients/guardians who do not meet the inclusion criteria
  • •patients/guardians who do not agree to participate in the study.
  • •child with chronic systemic disease
  • •non-cooperative children

研究组 & 干预措施

local anesthesia

Active Comparator

local anesthesia application before rubber dam isolation

干预措施: Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist (Other)

local anesthesia

Active Comparator

local anesthesia application before rubber dam isolation

干预措施: Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist (Other)

local anesthesia

Active Comparator

local anesthesia application before rubber dam isolation

干预措施: Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments (Other)

local anesthesia

Active Comparator

local anesthesia application before rubber dam isolation

干预措施: Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments (Other)

topical anesthesia

Active Comparator

topical anesthesia application before rubber dam isolation

干预措施: Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments (Other)

topical anesthesia

Active Comparator

topical anesthesia application before rubber dam isolation

干预措施: Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments (Other)

topical anesthesia

Active Comparator

topical anesthesia application before rubber dam isolation

干预措施: Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist (Other)

topical anesthesia

Active Comparator

topical anesthesia application before rubber dam isolation

干预措施: Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist (Other)

rubber dam

Active Comparator

Rubber dam isolation and evaluation of the associated objective and subjective stress parameters

干预措施: Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments (Other)

rubber dam

Active Comparator

Rubber dam isolation and evaluation of the associated objective and subjective stress parameters

干预措施: Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments (Other)

rubber dam

Active Comparator

Rubber dam isolation and evaluation of the associated objective and subjective stress parameters

干预措施: Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist (Other)

rubber dam

Active Comparator

Rubber dam isolation and evaluation of the associated objective and subjective stress parameters

干预措施: Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist (Other)

cotton roll

Active Comparator

cotton roll insulation and evaluation of the associated objective and subjective stress parameters

干预措施: Evaluation of objective and subjective stress parameters caused by local anesthesia during treatments (Other)

cotton roll

Active Comparator

cotton roll insulation and evaluation of the associated objective and subjective stress parameters

干预措施: Evaluation of objective and subjective stress parameters caused by topical anesthesia during treatments (Other)

cotton roll

Active Comparator

cotton roll insulation and evaluation of the associated objective and subjective stress parameters

干预措施: Evaluation of objective and subjective stress parameters caused by the application of rubber dam during treatments in the patient and dentist (Other)

cotton roll

Active Comparator

cotton roll insulation and evaluation of the associated objective and subjective stress parameters

干预措施: Evaluation of the objective and subjective stress parameters caused by the application of cotton rolls during treatments in the patient and dentist (Other)

结局指标

主要结局

blood pressure

时间窗: one week intervals about observation/treatment sessions (total time is 2 weeks)

systolic blood pressure and diastolic blood pressure for the children recorded. Systolic and diastolic blood pressure were measured using an automatic blood pressure monitor (mmHg). (min 20 mmHg- max 320 mmHg) The mean values and standard deviations of these measured values be taken into account.

pulse rate

时间窗: one week intervals about observation/treatment sessions (total time is 2 weeks)

pulse rate for the children and the operator recorded. Pulse rate was evaluated with a fingertip pulse oximeter (unit per minute) (min 60- max 160). The mean values and standard deviations of these measured values be taken into account.

blood pressure

时间窗: one week intervals about observation/treatment sessions (total time is 2 weeks)

systolic blood pressure and diastolic blood pressure for the children recorded. Systolic and diastolic blood pressure were measured using an automatic blood pressure monitor (mmHg). (min 20 mmHg- max 320 mmHg) The mean values and standard deviations of these measured values be taken into account.

pulse rate

时间窗: one week intervals about observation/treatment sessions (total time is 2 weeks)

pulse rate for the children and the operator recorded. Pulse rate was evaluated with a fingertip pulse oximeter (unit per minute) (min 60- max 160). The mean values and standard deviations of these measured values be taken into account.

次要结局

  • pain perception(one week intervals about observation/treatment sessions (total time is 2 weeks))
  • pain perception(one week intervals about observation/treatment sessions (total time is 2 weeks))

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ebru KUCUKYİLMAZ

PROFESSOR

Izmir Katip Celebi University

研究点 (1)

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