Evaluation of Post Operative Pain Following Indirect Pulp Treatment in Young Permanent Teeth Using Antibacterial Versus Conventional Two-Step Bonding System: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- change/evidence of post treatment spontaneous and provoked pain by questioning the patients
研究概览
简要总结
The aim of this study is to compare the clinical and radiographic success of indirect pulp capping of vital young permanent teeth with deep caries using two-step antibacterial bonding system versus conventional one.
详细描述
The study was carried out on patients attending outpatient clinic in Pediatric and Dental Public Health department- Faculty of Oral and Dental Medicine Cairo University- Egypt.
**Sample size: On searching, no previous studies were conducted using neither conventional bonding nor antibacterial bonding in indirect pulp treatment in young permanent teeth, so sample size will be measured by estimation rather than calculation.
So, all patients attended outpatient clinic in Pediatric and Dental Public Health department- Faculty of Oral and Dental Medicine Cairo University- Egypt, In the period from 1/8/2015 - 31/10/2015 were enrolled for this study if they compatible with eligibility criteria.
**Clinical Procedures:
I. Diagnosis:
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients free from any systemic diseases.
- •Young permanent molars with deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.
- •Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)
- •The absence of clinical symptoms of irreversible pulpitis such as spontaneous pain or pain persisting after the disappearance of the existing stimulus or sensitivity to pressure.
- •Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal membrane space, internal and external root resorption).
- •Compliant patient/parent.
排除标准
- •Teeth with previous restorative treatment.
- •Unrestorable teeth.
- •Uncooperative patients.
研究组 & 干预措施
Antibacterial Bond
Indirect pulp capping using antibacterial bond and x-tra fil composite
- Local anesthesia administration
- Isolation of tooth with rubber dam
- Opening of the cavity and the removal of undermined enamel
- Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed
- Partial removal of carious dentin on the pulp wall.
- Washing the cavity and dryness
- Apply antibacterial light-cure, self-etching bonding agent (Clearfil SE Protect, Kuraray America, Inc.)
- Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.
干预措施: Indirect pulp capping (Procedure)
Conventional Bond
Indirect pulp capping using conventional bond and x-tra fil composite
- Local anesthesia administration
- Isolation of tooth with rubber dam
- Opening of the cavity and the removal of undermined enamel
- Caries at the lateral walls of the cavity and at the dentin-enamel junction is completely removed
- Partial removal of carious dentin on the pulp wall.
- Washing the cavity and dryness
- Apply conventional light-cure, self-etching bonding agent (Clearfil SE Bond, Kuraray America, Inc.)
- Light-cured bulk fill composite (x-tra fil, VOCO) used as final tooth restoration.
干预措施: Indirect pulp capping (Procedure)
结局指标
主要结局
change/evidence of post treatment spontaneous and provoked pain by questioning the patients
时间窗: Immediate post operative, 2, 9 month
The patients are questioned if they experienced post-operative pain within the first 48 hours and then followed up after 2, 6, 9 month to check if there is a change in the situation and evidence of a complain
次要结局
- Absence of post treatment swelling(Immediate post operative, 2, 9 month)
- Absence of pain on percussion(Immediate post operative, 2, 9 month)
- Absence of adverse radiographic findings(Immediate post operative, 2, 9 month)
研究者
Shaimaa Mohamed Sabry Mostafa El Hanafy
Assistant Lecturer in Pediatric Dentistry and Dental Public Health Department
Cairo University