Quality of obturation, instrumentation time and post-operative pain using three different file systems in primary teeth - A randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To compare quality of Obturation and Instrumentation time using different Rotary file systems with Manual Instrumentation in Primary teeth
研究概览
简要总结
Pulpectomy is a procedure involving complete removal of pulp tissue from the root canal space in primary teeth followed by filling it with an inert resorbable material. Using hand files for instrumentation of the primary root canals has been well documented in the literature. There are certain potential limitations like increased canal preparation time, uneven preparation of root canal space associated with the use of hand files despite its widespread usage for the instrumentation of primary root canals. To overcome the disadvantages of the manual instrumentation and to preserve the tortuous root canal path of the primary teeth, rotary instrumentation was introduced into paediatric dentistry. An increasing volume of research acknowledges the significance of minimizing postoperative pain in pediatric endodontics using motorized instrumentation and specific pediatric rotary files. Hence, the present study intends to compare the quality of obturation, instrumentation time and intensity of postoperative pain using manual instrumentation and rotary instrumentation.
Aim: The aim of the study is to evaluate the quality of obturation, instrumentation time and postoperative pain using pedoflex file, kedo-SH, and reciprocating hand K-files in primary teeth.
Objectives: To compare the quality of obturation, instrumentation time and postoperative pain during root canal preparation.
To evaluate the obturation quality, instrumentation time during root canal preparation and intensity of postoperative pain after pulpectomy in primary teeth employing manual instrumentation(k-file) and rotary instrumentation (pedo flex file and kedo-SH file)
The randomized clinical trial was carried out in the Department of Paediatric and Preventive Dentistry,
Narayana Dental College and hospital, Nellore. The informed consent was obtained from the
parents of the children who participated in the study.
Children between 4-9 years of age requiring pulpectomy were randomly selected and allotted
to one of the three groups according to the computer generated randomization sequence where instrumentation was done using: Group 1: Manual K-files (15-30) (Mani); Group 2: Pedo Flex file; Group 3: Kedo-SH. The working length was determined with the pre-operative radiograph using Ingle’s radiographic method. Local anesthesia was administered using 2% lignocaine with 1:2,00,000 adrenaline. The tooth indicated for pulpectomy was isolated using rubber dam. Using No.6 round bur (Mani) was used in a high speed hand piece to remove the superficial caries and No.330 pear shaper bur (Mani) was used to completely de-roof thepulp chamber. No.10 size K file (Mani) was used to determine the patency of the canals. The canal preparation was done using:
Group 1: Twenty eight teeth were instrumented using K-files from size 15 to size 30 (Mani) in quarter pull turn method,
Group 2: Twenty-eight teeth were instrumented using Pedo Flex file,
Group 3: Twenty-eight teeth were instrumented using Kedo-SH file.
The time taken for the instrumentation of the canals was recorded in seconds using a stop watch by an assistant. The canals were then irrigated and obturated. A postobturation radiograph was taken to assess the quality of obturation. Pain assessment is done using Memoji’s pain scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged between 4-9 years who needed endodontic treatment, who signed the consent form.
- •2.Patient’s having pain during night.
- •3.Absence of internal or external pathologic root resorption 4.Vital or nonvital teeth without sinus tract.
- •5.Presence of adequate coronal tooth structure to receive stainless steel crown.
排除标准
- •1.Children lacking cooperative ability.
- •2.Children with underlying systemic diseases.
- •3.Children with special health care needs.
- •4.Children using continuous medication or who had taken analgesics or anti-inflammatories up to 12 hours before the procedure were excluded.
结局指标
主要结局
To compare quality of Obturation and Instrumentation time using different Rotary file systems with Manual Instrumentation in Primary teeth
时间窗: Post operative radiograph will be taken after obturation | Instrumentation time was recorded using stop watch
次要结局
- To compare Post-Operative pain using different Rotary file systems with Manual Instrumentation in Primary teeth(Pain assessment will be done after the procedure)
研究者
Shaik Sameera
Narayana Dental College and Hospital