Effect of bioceramic sealers on healing outcome and post operative pain: an in vivo study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.To evaluate healing outcome of bioceramic sealer
研究概览
简要总结
A clinical diagnosis for the patient reporting to the Department of Conservative Dentistry and Endodontics will be made and patients will be selected according to the inclusion criteria mentioned in the study. A preoperative radiograph and CBCT will be taken to assess the extent of caries and the size of periapical radiolucency which should be upto 5mm.Pulp vitality test(cold: ENDO ICE) and EPT will be performed to confirm the irreversible of the pulp.
Included patients will be informed about the study and explained in detail about the procedure of the study and requirement for the same. A solution of 2% lidocaine HCL and 1:100000 epinephrine will be used to anaesthetize each subject. Occlusal reduction will be done to avoid postoperative pain.
A sterile round bur #2 will be used to get access to the pulp chamber coronally after debriding the tooth structure of any old restoration and secondary decay around the access opening site. To establish the working length, radiographic method will be employed. An initial glide path will be prepared with a hand file after the working length has been established. Canal orifice enlargement will be done with SX hand protaper file for each patient.
Continue with the root canal treatment by doing further biomechanical preparation with
size F1 until the projected working length is reached, irrigation with 2.5 percent NaOCl and
saline will be performed as per gold standard, and the final rinse will be done using 3ml of
17% EDTA. The canal will then be dried using paper points. Depending upon the type of
sealer used 100 patients will be randomly allocated into 2 groups of 50 patients each.
Group 1 (n=50): Bioceramic sealer(bio c sealer, Angelus)
Group 2 (n=50): Resin based sealer (AH plus, Dentsply)
Both the sealers will be mixed as per manufacturers instruction. Root canal walls will be coated with the sealer with the help of master cone GP followed by lateral compaction with accessory GP cone. Gutta percha cone will be cut at orifice level. After obturation teeth will be assessed for
Post operative pain
Healing of apical radiolucency
If patient complains of pain after obturation a escape drug (diclofenac sodium tablets 40mg)will be given. Post Operative Pain will be checked at 4 hr, 24 hr and 48 hr. Pain will be measured by NRS Scale. Healing will be checked by Periapical Radiograph & CBCT. Periapical Radiograph Will Be Taken At**:**
pre operative
3 months
6 months
12 months
CBCT Will Be Done At:
Pre operative
After 12 months
Healing will be checked by Periapical Index (PAI) Score and Cone-beam computed tomography – Periapical index (CBCT-PAI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Both male and female genders.
- •2.Age of patient between 18-60 years.
- •3.Teeth with fully formed apices requiring root canal therapy.
- •4.Posterior teeth.
- •5.Horizontal supracrestal root fracture.
- •6.Good health(AMERICAN SOCIETY OF ANESTHESIOLOGISTS CLASSIFICATION I AND II.) 7.Presence of periapical radiolucency upto 5mm.
- •8.Irreversible pulpitis ( SYMPTOMATIC/ ASYMPTOMATIC)
- •Patient consenting to be part of this study.
排除标准
- •Use of any analgesic, anti inflammatory or antibiotics before treatment.
- •Previous endodontic intervention.
- •Evidence of vertical root fracture.
- •Non restorable teeth.
- •Patient who were unable to communicate their symptoms because of psychological disorders.
- •Tooth was affected by cracks, severe periodontal bone loss due to chronic periodontitis accompanying mobility of tooth.
结局指标
主要结局
1.To evaluate healing outcome of bioceramic sealer
时间窗: healing will be checked at base line 3 months 6 months and 12 months interval
2. to evaluate healing outcome of resin based sealer
时间窗: healing will be checked at base line 3 months 6 months and 12 months interval
3. to compare healing outcome of bioceramic sealer
时间窗: healing will be checked at base line 3 months 6 months and 12 months interval
4. to compare healing outcome of resin based sealer.
时间窗: healing will be checked at base line 3 months 6 months and 12 months interval
次要结局
- To evaluate and compare the intensity of pain after obturation using BC sealer and Resin based sealer.2.To evaluate and compare the intensity of pain after obturation using BC sealer and Resin based sealer.
研究者
Dr Ankita Sharma
ITS dental college hospital and research centre, greater noida