Evaluation of Success Rate of Non Vital Mature Anterior Teeth With Periapical Lesion Following Single Versus Two Visit Regenerative Treatment Protocol A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Change in Post operative pain: NRS
研究概览
简要总结
This study evaluates success rate of non vital mature anterior teeth with periapical lesion treated by regenerative endodontic protocol in single visit versus two visit technique.
Patients are randomized into two groups where treatment will be done either in one visit including access, disinfection, placing platelet rich plasma as scaffold and restoration or two visit protocol involving access, disinfection and placing calcium hydroxide as intracanal medicament in first visit followed by a second visit after 3 weeks involving reopening of the tooth, removing intracanal medicament and placing platelet rich plasma as scaffold then restoration. Success rate is defined as absence of subjective signs and symptoms along with healing of periapical lesion
详细描述
Title: Evaluation of Success Rate of Non Vital Mature Anterior Teeth with Periapical Lesion Following Single versus Two Visit Regenerative Treatment Protocol (A Randomized Clinical Trial) Regenerative endodontics can be defined as biologically based procedures designed to replace damaged structures, including dentin and root structures, as well as cells of the pulp-dentin complex.
The majority of endodontic patients are adults, thus the application of the tissue engineering concept to mature teeth could provide a biological treatment modality instead of the conventional one. In fact, several advantages were reported about regenerative procedures in well developed mature teeth. Reconstitution of the neurovascular system in root canals by pulp regeneration will provide pulp tissues with an immune system, which will function as the first line of defense against microbial challenge. Moreover, restoration of pulp dentine complex will protect the tooth during loading and mastication.
Different treatment protocols for pulp regeneration were reported in the literature regarding irrigation (type, concentration and time), intracanal medication, pulpal space barrier, incorporation and lack of scaffolds (blood clot, PRP,PRF, collagen) as well as recall visits.
Rationale for conducting the research and choice of comparators:
Multiple visits protocol has been the commonly used technique in regenerative endodontic procedures. It involves the placement of intracanal medicaments between visits (calcium hydroxide and triple antibiotic paste) which have many drawbacks such as difficulty in removal, tooth discoloration, weakening of the root and tooth loss.
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 (Outcomes Assessor)
盲法说明
single
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single canal anterior tooth
- •Mature root
- •Non vital with radiographic evidence of periapical lesion
- •Periapical lesion of average size 2-5mm
- •Positive patient compliance for participation in the study.
- •Patients with good oral hygiene
- •Normal periodontal probing depth ≤ 3 mm
排除标准
- •Compromised remaining tooth structure that need post and core build up
- •Non restorable teeth
- •Vital teeth
- •Radiographic evidence of external or internal root resorption.
- •Roots showing fracture or ankylosis
- •Medically compromised patients
- •Pregnant women
- •Greater than grade I mobility or periodontal probing depth greater than 3mm
- •Immature tooth
- •Patients with pain, swelling or fistula tracts
研究组 & 干预措施
Single visit pulp regeneration
Regenerative endodontic procedure not involving placement of intracanal medicament will be done in single visit
干预措施: Single visit pulp regeneration (Procedure)
Two visit pulp regeneration
Regenerative endodontic procedure involving placing intracanal medicament will be done in two visit
干预措施: Two visit pulp regeneration (Procedure)
结局指标
主要结局
Change in Post operative pain: NRS
时间窗: 3, 6, 9 and 12 months
absence of pain reported by the patient by numerical rate scale, the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Change in swelling and/or sinus
时间窗: 3,6,9,12 months
The presence of swelling or sinus will be reported by a binary question yes/no
Periapical healing
时间窗: 12 months
The existing periapical lesion will be measured by mm by CBCT before intiation of treatment and after one year
次要结局
- Antimicrobial effect(before and after complete disinfection either in the same visit or after 3 weeks from the second visit)
- Sensitivity(3, 6, 9 and 12 months)
- Discoloration(3, 6, 9 and 12 months)
研究者
lamiaa Mohamed Ragaei Lasheen
Assistant lecturer of endodontics
Cairo University