Comparative Evaluation of Pulpotomy as a Conservative Treatment Option in Symptomatic Irreversible Pulpitis Using Three Different Bioceramic Materials Versus Pulpectomy : A Randomized Clinical Study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- This will be performed for postoperative pain after 24 hrs and 1 week using
研究概览
简要总结
Dental caries causes gradual weakening of tooth enamel, leading to inflammation of the tooth pulp if left untreated. This persistent infection is a major global health concern, with untreated cavities being widespread, affecting approximately 34.1% of the population worldwide.
Managing dental decay involves preventing it through primary preventive methods and removing decayed tissue through operative interventions. Preserving the health and vitality of the tooth pulp, preventing complications like abscess formation, and developing minimally invasive biological treatments are key focuses in modern clinical practice.[1,6]
In cases of irreversible pulpitis, the histological condition of the pulp may not always correlate with the clinical diagnosis. Studies have shown that even in advanced inflammation, only certain areas of the coronal pulp show bacterial invasion, while the underlying pulp remains unaffected. It has also been revealed that after the removal of the infected coronal pulp, the remaining pulp tissue has excellent regenerative capabilities.[5]
Traditionally, root canal
treatment (RCT) has been the recommended approach for irreversibly inflamed
pulp following exposure to decay [2]. Although
nonsurgical root canal treatment (RCT) has positive results, it also comes with
drawbacks such as advanced equipment, higher expenses, and occasionally
requiring multiple appointments [3]. The management of
irreversible pulpitis has been reevaluated in recent years due to increasing
evidence from clinical trials demonstrating positive outcomes of vital pulp
therapy (VPT) in such cases. Consequently, professional societies have issued
new position statements regarding the treatment of teeth with carious pulp
exposure and diagnosed with reversible or irreversible pulpitis (AAE, 2021;
Duncan et al., 2019) [3].
Vital pulp therapy (VPT) is viewed as a simpler and more cost-effective approach compared to traditional methods like pulpectomy and root canal filling. Among VPT methods, pulpotomy and indirect pulp capping have proven to be a more reliable and successful intervention compared to direct pulp capping procedures.[4]
With advancements in understanding pulp biology and the use of newer materials, the concept of "vital pulp therapy" (VPT) has been revisited, leading to successful outcomes in teeth with carious pulp exposures or pulpitis.[4]
Pulpotomy is a surgical procedure where the coronal part of the pulp tissue is removed to protect the radicular part, encouraging the growth of dentin bridge using various materials to cover the remaining pulp tissue, taking advantage of the pulp cells’ ability to form dentin.[6]
There’s a belief that if a pulpotomy fails, retreatment might be easier compared to a root-filled tooth. Both the European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) now endorse VPT as a viable treatment for symptomatic carious pulp exposure. The ESE’s 2019 position aimed to change clinicians’ mindset, advocating for VPT instead of immediately resorting to root canal treatment (RCT).[2]
(add about the ‘position statement by AAE and ESE about use of VPT’ application of same in prim teeth, for ref AAPD 2024 guidelines. Then a line or two about disinfecting agents in VPT for sym irr pulpitis like NaOCl and recent being laser)
Sodium hypochlorite (NaOCl) is one such agent recognized and recommended for its dual effectiveness as a haemostatic and antibacterial agent in dental procedures. It has been found to have no negative impact on pulp repair, healing, or tertiary dentinogenesis. Studies have examined its use in controlling pulpal haemorrhage during pulpotomy in primary teeth, with current research endorsing its safe application at concentrations between 1% to 5% for vital pulp therapy procedures.[8,9]
Recent studies show, that Nd: YAG, Er: YAG, CO2, and diode lasers have become popular for pulpotomy due to advantages like improved haemorrhage control, and stimulation of regenerative cells. Among these, diode lasers have the benefit of causing less thermal damage and promoting faster pulpal wound healing because the dental pulp has a high-water content, which enhances the absorption of diode laser wavelengths. Studies have shown diode lasers to be more effective than other treatments for pulpotomy in primary molars.[7] (talk about lasers as a disinfecting agent ONLY and not as a pulpotomy agent)
Historically, VPT faced challenges due to misconceptions about pulp healing and limited material options. Calcium hydroxide was traditionally used, but its success rate was lower than MTA.[7]A full pulpotomy with haemostasis and coronal pulp coverage using calcium silicate cement (CSCs) can be successful. The AAE’s 2021 position statement also supports direct visualization and achieving haemostasis to assess the suitability of pulpotomy for teeth with symptomatic irreversible pulp, emphasizing the use of CSCs and immediate coronal restoration.[2]
MTA is a bioactive substance, that excels in forming apatite and sealing, with high pH, radiopacity, and biocompatibility. Despite its strengths.[7] An alternative material Bio dentine was developed as a dentine substitute; it shows great results with its short setting time and similar biocompatibility to MTA. MTA putty, another calcium silicate-based material, developed using bio-ceramic technology, is designed in pre-mixed injectable form as a clinical substitute for MTA.
It has superior handling, improved colour stability, adaptability, and comparable physical and chemical properties to MTA. Importantly, it releases calcium and phosphate ions necessary for hydroxyapatite deposition.[7]
So, the present study aims to evaluate the success rate of pulpotomy with 3 different CSC in symptomatic irreversible pulpitis in primary teeth as a treatment option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy (ASA I and II) co-operative children (Frankl Scale + and ++).
- •Children of age group 4 to 9 years.
- •The pulp of the affected primary tooth must be vital.
- •Participants with symptoms of symptomatic irreversible pulpitis in one of the primary teeth.
- •The affected primary teeth must be restorable with crowns.
- •2/3rd of the root length should be present.
排除标准
- •Clinical examination of affected primary teeth reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling)
- •Pre-operative periapical radiograph suggests the presence of furcal radiolucency of more than ½ the furcation to the periapical area.
- •Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
- •Teeth with the pulp chamber exposed to the oral environment.
- •If haemostasis is not achieved within 10 min after application of gentle pressure with sterile cotton soaked in 2.5% sodium hypochlorite.
- •Parents not willing to place full coverage restoration post-pulpotomy.
- •Medically compromised patients.
结局指标
主要结局
This will be performed for postoperative pain after 24 hrs and 1 week using
时间窗: 12 months
the Numerical Rating Scale from 0-10 (NRS) from Taha et al;2021).
时间窗: 12 months
Clinical failure will be determined (3,6 and 12 months) by the subjective
时间窗: 12 months
symptoms as explained by the participants, and objective signs as recorded
时间窗: 12 months
during clinical examination including abscess, swelling, sinus tract and
时间窗: 12 months
tenderness associated with the tooth.
时间窗: 12 months
Radiographic assessment
时间窗: 12 months
Post-operative radiographs will be obtained at 3 months, 6 months, and 12
时间窗: 12 months
months.
时间窗: 12 months
次要结局
- Postoperative sensitivity & pain will be evaluated(1 month)
研究者
Amol Patil
M.A. Rangoonwala College of Dental Sciences and Research Centre
