Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Root Canal Obliteration
研究概览
简要总结
The aim of this study is to evaluate the clinical and radiographic outcomes of Chitosan scaffold and Mineral trioxide aggregate (MTA) when used as pulpotomy agents in mature permanent teeth with irreversible pulpitis.
详细描述
Thirty permanent mandibular molars of patients with signs and symptoms of irreversible pulpitis will be selected. They will be randomly allocated into two groups, Group 1(Chitosan scaffold/ MTA pulp dressing materials), Group 2 (MTA pulp dressing material). A single visit full pulpotomy procedure will be carried out. Chitosan scaffold and / or MTA will be used as the pulp dressing materials. The teeth will be then restored with base of Glass ionomer cement followed by composite restoration.
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)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants free from any systemic disease.
- •Deep caries in a permanent lower molar with mature roots.
- •Probing pocket depth and mobility within normal limits.
- •No signs of pulpal necrosis including sinus tract or swelling.
- •Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
- •The tooth is restorable.
- •Clinical diagnosis of symptomatic irreversible pulpitis based on subjective and objective examinations:
- •Subjective examination: Patients complaining of intermittent or spontaneous pain or pain exacerbated by dramatic temperature changes especially to cold stimuli and lasting for a few seconds to several hours.
- •Objective examination:
- •Clinical examination: Teeth that will experience immediate, excruciatingly painful sensation as soon as the cold stimulus is placed on and which may last for a while even after the removal of the stimulus.
- •Radiographic examination: Preoperative radiographs will be taken using a paralleling device.
- •The periapical index developed by Orstavik et al. (1986)(35) will be used to score cases with periapical rarefaction during diagnosis and follow-up periods. It consists of five categories:
- •Normal periapical structures.
- •Small changes in bone structures.
- •Change in bone structure with mineral loss.
- •Periodontitis with well-defined radiolucent area.
- •Severe periodontitis with exacerbating features. Score 1 and 2 are considered healthy, score 3-5 are considered diseased
- •The teeth that will be included should have score 1 or 2.
排除标准
- •Negative response to cold testing.
- •No pulp exposure after caries excavation.
- •Bleeding could not be controlled in 10 minutes after 2.5% NaOCl
- •Absence of bleeding from any of the canals.
- •Teeth with radiographic signs of internal resorption.
- •Pulpal calcifications.
- •Participants with stainless-steel wires and brackets.
研究组 & 干预措施
Chitosan scaffold/ MTA pulp dressing material
干预措施: Chitosan scaffold/ MTA pulp dressing material (Drug)
MTA pulp dressing material
干预措施: MTA pulp dressing material (Drug)
结局指标
主要结局
Root Canal Obliteration
时间窗: 12 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Internal Root Resorption
时间窗: 12 months
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Pain Assessment
时间窗: one week
Postoperative pain will be recorded on Numerical Rating Pain Scale (NRS) that will be given to the patient to record his pain intensity in the range between 0-10, until the seventh day after treatment. Pain on the NRS will be further categorized as: No pain (0), Mild (1-3), Moderate (4-6), and Severe (7-10) pain.
Mineralization Activity
时间窗: 12 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
次要结局
- Peri-radicular/furcal pathosis(12 months)
- Changes in the dental pulp in treated teeth(6 months)
- Internal and external root resorption(12 months)
研究者
Nourhan M.Aly
Instructor of Dental Public Health and Statistician
University of Alexandria