Effects of TheraCal PT, Biodentin, and MTA on Postoperative Pain After Full Pulpotomy in Permanent Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Measurement of postoperative pain caused by TheraCal PT, Biodentin and MTA application at 6, 24, 48, 72 hours and 7 days
研究概览
简要总结
In this study, the researchers will evaluate the effect of three highly biocompatible materials-TheraCal PT (ThPT), Biodentin, and MTA-on postoperative pain in permanent teeth affected by deep caries and symptomatic irreversible pulpitis.
Participants:
The study will include 51 participants aged between 18 and 45 years who are systemically healthy.
Methodology:
Pulpotomy Procedure:
Pulpotomy will be performed on the lower first molar tooth of each participant. The teeth will be randomly divided into three groups, with 17 participants in each group. Coronal pulp tissue will be removed using a high-speed sterile diamond bur. Hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl, and this procedure may be repeated up to three times (totaling 6 minutes) if necessary.
Use of Biocompatible Materials:
After achieving hemostasis, one of the three biocompatible materials (TheraCal PT, Biodentin, or MTA) will be applied to the canal access. Participants will be prescribed NSAIDs.
Pain Assessment:
Preoperative Assessment : The pain intensity of participants will be recorded before treatment.
Postoperative Assessment : Participants will report their pain intensity at the 6th, 24th, 48th, and 72nd hours and on the 7th day using the Visual Analogue Scale (VAS). Participants will return with their VAS charts for evaluation at the end of one week.
Comparative Analysis:
The primary outcome will be a comparative evaluation of postoperative pain intensity values among the three different materials used in pulpotomy treatment. This study aims to provide valuable information on the effectiveness of various biocompatible materials in postoperative pain management and to contribute to improving clinical decision-making processes in endodontic treatments.
详细描述
The ethical approval for our study has been obtained from the Clinical Research Ethics Committee of Sivas Cumhuriyet University. The experimental phase of the study will be conducted at the Department of Endodontics, Faculty of Dentistry, Sivas Cumhuriyet University.
Patient Selection Criteria:
Participants aged between 18 and 45, who present with findings of irreversible pulpitis in the lower first molar tooth and apply to the Department of Endodontics, Faculty of Dentistry, Sivas Cumhuriyet University, will be included in the study.
In this study:
When α=0.05, β=0.10, and 1-β=0.90 were set, it was decided to include 17 teeth in each group, and the power of the test was found to be p=0.90948.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range should be between 18 and 45,
- •Systemic disease should be absent,
- •Apical periodontitis findings may or may not be present,
- •Irreversible pulpitis symptoms should be present,
- •The apex of the tooth should be closed,
- •Pulp sensitivity tests (cold test and electric pulp test) should respond positively,
- •Periodontal pocket depth and mobility should be within normal limits,
- •Rubber dam isolation should be provided for the tooth to be treated,
- •Restorative treatment of the tooth should be performed,
- •The patient's mouth opening should be sufficient.
排除标准
- •The patient has any systemic disease (including conditions requiring prophylaxis),
- •The patient has mental or psychiatric disorders,
- •The patient has any allergic condition,
- •The patient has used painkillers in the last 12 hours before the procedure and antibiotics in the last week,
- •There is a loss of material in an amount that cannot be restoratively treated,
- •The presence of a fistula tract or abscess,
- •A negative response to pulp sensitivity tests (cold test and electric pulp test),
- •No bleeding in the pulp or failure to achieve hemostasis within 6 minutes after total pulpotomy,
- •The apex is open,
- •Advanced canal calcification is observed on periapical radiography,
- •The presence of internal or external root resorption.
研究组 & 干预措施
Biodentine Application Procedure
After the coronal pulp tissue of the tooth is removed using a high-speed sterile diamond bur, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this may be repeated up to 3 times (for a total of 6 minutes) if necessary. Once bleeding control is established, Biodentin material will be placed at the canal openings. After a waiting period of 12 minutes according to the manufacturer's instructions, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as a base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.
干预措施: TheraCal PT pulpotomy (Biological)
Biodentine Application Procedure
After the coronal pulp tissue of the tooth is removed using a high-speed sterile diamond bur, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this may be repeated up to 3 times (for a total of 6 minutes) if necessary. Once bleeding control is established, Biodentin material will be placed at the canal openings. After a waiting period of 12 minutes according to the manufacturer's instructions, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as a base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.
干预措施: MTA pulpotomy (Biological)
TheraCal PT Application Procedure
After the coronal pulp tissue of the tooth is removed using a high-speed sterile diamond bur, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this may be repeated up to 3 times (totaling 6 minutes) if necessary. Once bleeding control is established, TheraCal PT material will be placed. According to the manufacturer's instructions, after a 10-second irradiation period, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as a base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.
干预措施: Biodentine pulpotomy (Biological)
ProRoot MTA Application Procedure
The coronal pulp tissue of the tooth will be removed using a high-speed sterile diamond bur. Then, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this procedure may be repeated up to 3 times (totaling 6 minutes) if necessary. After confirming bleeding control, ProRoot MTA material will be placed at the canal openings. Following a waiting period of 15 minutes, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as the base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.
干预措施: TheraCal PT pulpotomy (Biological)
ProRoot MTA Application Procedure
The coronal pulp tissue of the tooth will be removed using a high-speed sterile diamond bur. Then, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this procedure may be repeated up to 3 times (totaling 6 minutes) if necessary. After confirming bleeding control, ProRoot MTA material will be placed at the canal openings. Following a waiting period of 15 minutes, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as the base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.
干预措施: Biodentine pulpotomy (Biological)
TheraCal PT Application Procedure
After the coronal pulp tissue of the tooth is removed using a high-speed sterile diamond bur, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this may be repeated up to 3 times (totaling 6 minutes) if necessary. Once bleeding control is established, TheraCal PT material will be placed. According to the manufacturer's instructions, after a 10-second irradiation period, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as a base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.
干预措施: MTA pulpotomy (Biological)
结局指标
主要结局
Measurement of postoperative pain caused by TheraCal PT, Biodentin and MTA application at 6, 24, 48, 72 hours and 7 days
时间窗: 6, 24, 48, 72 hours and 7 days
In the study, TheraCal PT, Biodentin, and MTA materials will be applied to teeth with irreversible pulpitis. Preoperative pain values and postoperative pain values at 6, 24, 48, 72 hours and on the 7th day will be recorded. The preoperative and postoperative values of TheraCal PT, Biodentin, and MTA materials will be evaluated comparatively.
次要结局
未报告次要终点
研究者
Fatos Albayrak
Assistant Professor
Cumhuriyet University