Effect of Thickness Variation in Coronal Plug on Root Maturation and Periapical Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Root maturation
研究概览
简要总结
d. Second visit:
After 3 weeks the patients will be randomly divided into 2 groups:
Group A:
Patients will be anesthetized 1 carpule of mepivacaine without vasoconstrictor (Mepivacaine HCl 3%), the access will be reopened under rubber dam isolation and the canal will be irrigated with a total of 20 ml of 1.5-2.5% sodium hypochlorite solution. The canal will then be dried with sterile paper points; a sterile sharp needle will be used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process.
Over a 15-minute time period, the blood will be allowed to clot to a level of 3 mm below the cemento-enamel junction. A resorbable matrix such as CollaPlug™, Collacote™, CollaTape™ will be placed over the blood clot if necessary. Then 3 mm of MTA will be placed using a suitable size amalgam carrier. A damped cotton pellet on a tweezer placed above the unset MTA and large condenser will be used to seal the canal orifice completely. The access cavity will be sealed with Fuji IX glass ionomer filling material and acid etched composite resin bonded filling material.
Group B:
The same procedures that will be followed in group A will be also done in group B, except for the thickness of MTA coronal plug which will be 5mm in its thickness
e. Follow-up:
The patients will be recalled after 1, 6 and 12 months for follow up. The post-treatment follow-up examination will be accomplished as follows:
- CBCT scan will be done at 6 and 12 months follow up appointments.
- An evaluation was performed on each patient to assess presence of any signs and symptoms clinically by inspection, percussion, palpation, or biting on the treated tooth.
详细描述
4.1. Trial Design: The trial design of this study is a prospective, 2-arm, 1:1, parallel, randomized, clinical trial (RCT). In RCT, participants are allocated at random to receive one of several interventions according to the research plan created by the investigators. These interventions may be drug, placebo or certain procedure which is not usually known whether it will be helpful, harmful or with no difference than the available alternatives. In RCT the outcomes are measured, so it is considered a quantitative study. This trial design methodology conforms to the Consolidated Standard of Reporting Trials (CONSORT).
4.2. Participants:
a. Sample size: Teen participants will be selected from the out patients of the endodontic clinic Faculty of dentistry, Ain Shams University), 9 cases in each group .
4.3. Randomization: Randomization is a process that assigns research participants by chance, rather than by choice, to either the experimental group or the control group. The goal of randomization is to produce comparable groups in terms of general participant characteristics, such as age, gender, chief complain, time pass after trauma, and the other key factors that affect the probable course the disease would take. In this way, the 2 groups are as similar as possible at the start of the study. At the end of the study, if one group has better outcome than the other, the investigators would be able to conclude with some confidence that one intervention is better than the other.
Randomization process was achieved in three steps:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients were medically free [American Society of Anesthesiologists (ASA) Class I or II].
- •Age ranging between 10-18 years old.
- •No sex predilection.
- •Patients having asymptomatic and/or symptomatic immature necrotic anterior teeth.
排除标准
- •Patients with a history of allergy to any of the material used in the study.
- •Patients with systemic diseases (e.g. diabetes mellitus, bleeding disorders, heart diseases, liver diseases, kidney diseases, genetic disorders and syndromes).
- •Psychologically disturbed patients.
- •Teeth that needed a post and core as the final restoration.
- •Patients who had teeth with periodontal pockets more than 3 mm or generalized chronic periodontitis
- •Teeth with developmental anomalies (i.e., dens invaginatus or a palatogingival groove)
- •Patients who had radiographic evidence of external / internal root resorption or cystic lesion.
- •Patients refused participating in the study.
结局指标
主要结局
Root maturation
时间窗: after 12 month
after superimposition of the pre and post operative CBCT percentage growth of the root was calculated after 1. measuring the root length in millimeter in the pre and post operative CBCT increase in length = (follow up length - base line length). 2. Amount of radiographic increase in the root dentinal wall thickness Dentin thickness in the post operative CBCT = (root thickness-pulp space) and was compared to the baseline CBCT radiograph. The increase in thickness was calculated as follows: increase in thickness = (follow-up thickness -base line thickness). 3. measuring the decrease of apical diameter: Using the preset measurement scale, the diameter of the apical foramen was measured in millimeters on the 12 months follow up CBCT radiograph and was compared to the baseline CBCT radiograph (decrease of apical diameter = follow-up apical diameter-base line apical diameter).
Root maturation
时间窗: after 12 month
after superimposition of the pre and post operative CBCT percentage growth of the root was calculated after 1. measuring the root length in millimeter in the pre and post operative CBCT increase in length = (follow up length - base line length). 2. Amount of radiographic increase in the root dentinal wall thickness Dentin thickness in the post operative CBCT = (root thickness-pulp space) and was compared to the baseline CBCT radiograph. The increase in thickness was calculated as follows: increase in thickness = (follow-up thickness -base line thickness). 3. measuring the decrease of apical diameter: Using the preset measurement scale, the diameter of the apical foramen was measured in millimeters on the 12 months follow up CBCT radiograph and was compared to the baseline CBCT radiograph (decrease of apical diameter = follow-up apical diameter-base line apical diameter).
次要结局
- periapical healing(12 month)
- periapical healing(12 month)
研究者
Rania ElSayed Soliman
assistant lecturer
Benha National University