Postoperative Pain and Flare-Up Incidence Following the Use of Bio Ceramic Based Intra-Canal Medication in Diabetic Type II Patients (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
- 56
- 主要终点
- postoperative pain intensity
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the Postoperative Pain and Flare-Up incidence following the use of Bio-Ceramic Based Intra-Canal Medication in Diabetic type II Patients compared to the Calcium Hydroxide based Intra-canal medicament.
The main questions it aims to answer are:
- Is there any difference between using the two intracanal medicaments in the aspects of postoperative pain and flare-up incidence in diabetic type II patients?
- Do intracanal medications reduce postoperative pain and flare-up incidence in diabetic type II patients?
Participants will be divided into two groups:
( both groups will receive root canal treatment in single rooted teeth) then: First group: will receive "Calcium Hydroxide based" intracanal medicament Second group: will receive "Bio-Ceramic Based" intracanal medicament
Postoperative pain will be assessed using:
- visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before.
- Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Flare-up is assessed:
- by asking the patient to notify the investigator if any sudden severe pain or swelling takes place.
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
Participants will be blinded to the type of intracanal medicament used during their root canal treatment. The medicaments will be applied in a manner that prevents participants from identifying which treatment they received.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with controlled diabetes mellitus type II.
- •Necrotic single rooted teeth:
- •with periapical lesion ranging (1-2mm) in diameter.
- •with complete root formation.
- •Without calcified root canals.
- •Without root caries.
- •Without external or internal root resorption.
- •Without anatomical abnormalities such as fusion.
排除标准
- •Pregnant females.
- •Patients with other systemic diseases in combination with diabetes mellitus.
- •Patients under antibiotic or analgesic administration.
- •Patients with facial swelling.
- •Teeth that are not indicated for endodontic treatment: bad oral hygiene, mobile teeth, or recessed teeth.
- •Previously endodontically treated teeth.
- •Teeth with sinus tract.
研究组 & 干预措施
Calcium Hydroxide Group (GROUP I)
Treated using calcium hydroxide as an intracanal medicament (n=28)
干预措施: Calcium Hydroxide Intracanal medication (Drug)
Bioceramic Group (GROUP II)
treated using bio-ceramic based material as an intracanal medicament (n=28)
干预措施: bioceramic based intracanal medication (Drug)
结局指标
主要结局
postoperative pain intensity
时间窗: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before. Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
Flare-Up Incidence
时间窗: Within 7 days post-treatment
Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place. This could require an unscheduled emergency visit or prescription of additional medication.
次要结局
未报告次要终点
研究者
Abdulrahman Issam Abdulkareem Marie
Postgraduate Student, Department of Endodontics
Minia University