Comparison of Two Root End Filling Techniques during Endodontic Microsurgery of Permanent Anterior Teeth: A Parallel Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 1. To evaluate the clinical and radiographic
研究概览
简要总结
Periapical lesions are a common outcome of pulpal infections often leading to the
need for endodontic intervention. While conventional root canal therapy (RCT)
serves as the primary mode of treatment for infected or necrotic pulps, there are
cases where it does not yield the desired therapeutic outcome. When nonsurgical
retreatment fails or is unlikely to succeed, surgical intervention becomes necessary,
making endodontic microsurgery (EMS) a crucial treatment option. This
microsurgical technique, enhanced by magnification tools such as surgical
microscopes and loupes, allows precise surgical intervention to address unresolved
periapical infections. EMS results in high long-term healed (78.3%) and survival
(95.2%) rates
The most critical step of EMS is Root End Filling which comprises of root end
resection, root end preparation and root end filling. Root end resection involves
removal of 3 mm of the root apex, followed by retrograde preparation of canal by
ultrasonic tips and retro-filling it with a biocompatible material. However, it is
more technique-sensitive, as it involves working within a small surgical field under
magnification. Furthermore, there is a risk of the filling material being washed out
before it sets properly due to a lack of effective hemostasis around the root-end
area. Retrograde placement necessitates specialized armamentarium and
preparation of the root-end before placing the filling material carries a risk of
initiating or propagating microcracks, which may eventually result in vertical root
fractures.
There is a concept of ―orthograde technique,‖ which has been proposed. In this,
after completion of biomechanical preparation and achieving a dry canal , the root end
filling material like MTA/Bio dentine is introduced into the root canal space
to about 7 mm from the root apex, followed by obturation of the root canal. The
surgery is performed after 3-5 days. Surgery involves resecting the root end
eliminating the need of retro preparation and retro-filling. This can potentially
reduce postoperative discomfort, including pain and swelling. Wash out of the set.
material is prevented from blood contamination and there is no need of specialized
armamentarium such as ultrasonics reducing the risk of dentinal microcracks.
The efficacy of orthograde technique has been evaluated in few in vitro and animal
studies. Andelin et al (2002) conducted a dye leakage study on 46 extracted teeth
to evaluate the effect of resection on the microleakage of MTA. They found no
significant difference in leakage in teeth with resected MTA or in those with MTA
placed as a retrograde root-end filling material. A micro-CT study (2022) found
no significant difference among the two techniques regarding the total volume of
voids in the root canal of extracted single rooted teeth. Another in vitro study
(2023) found that the retrograde method offered superior marginal adaptation,
while the orthograde method demonstrated greater resistance to dislodgement. An
animal study by Apaydin et al (2003) compared the effects of fresh and set
mineral trioxide aggregate (MTA) on hard tissue healing after peri radicular
surgery. Root canals of 24 mandibular premolars in four 2-year-old beagle dogs
were filled with MTA. After two weeks, half of the roots were resected to the set
MTA, while the other half were prepared ultrasonically and filled with fresh MTA.
Four months later, histomorphometry analysis revealed that fresh MTA led to
significantly higher cementum formation (12/12 vs. 8/12, p = 0.028), but there was
no notable difference in the amount of cementum or bone healing between the two
groups. Another animal study (2011) reported no significant difference in
inflammation or hard tissue healing between the two techniques, though fresh
MTA showed slightly better outcomes.
Despite the presence of favorable in vitro and animal studies, there is no clinical
evidence directly comparing their outcomes of these two techniques. Thus,
conducting a comparative clinical study is essential to assess which method offers
better clinical success and patient outcomes. Hence the proposed randomized
clinical trial aims to compare the outcomes of orthograde and retrograde
placement of root-end filling materials during endondontic microsurgery in
permanent anterior teeth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
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.Patients aged 18–60 years 2.Non-vital anterior teeth with single canal 3.Patients with Symptomatic Apical Periodontitis and Persistent apical periodontitis after NSET scheduled for periapical surgery with large (greater than 5mm) periapical lesion 4.Adequate access to apical third of the root.
排除标准
- •1.Patients with systemic conditions affecting healing (e.g., diabetes) 2.Teeth with vertical root fractures 3.Apico-marginal defect 4.Patients with inadequate oral hygiene or periodontal health 5.Pregnant or lactating women.
结局指标
主要结局
1. To evaluate the clinical and radiographic
时间窗: 6 months and 1 year
outcome of orthograde placement of root-end
时间窗: 6 months and 1 year
filling material followed by root end resection
时间窗: 6 months and 1 year
during endodontic microsurgery in permanent
时间窗: 6 months and 1 year
anterior teeth.
时间窗: 6 months and 1 year
2. To evaluate the clinical and radiographic
时间窗: 6 months and 1 year
outcome of conventional retrograde placement
时间窗: 6 months and 1 year
of root-end filling material following root end
时间窗: 6 months and 1 year
resection and preparation during endodontic
时间窗: 6 months and 1 year
microsurgery in permanent anterior teeth.
时间窗: 6 months and 1 year
3. To compare the above
时间窗: 6 months and 1 year
次要结局
- To evaluate the postoperative pain, swelling,(analgesics needed, and patient reported quality)
研究者
Dr Fiyaz Ghan A S
Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
