Clinical and Radiographic Evaluation of Bioactive Materials in Pulp Therapy of Primary Teeth: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinical Success of Pulpotomy Treatment after 3 months follow up
研究概览
简要总结
The purpose of this study is to compare the clinical and radiographic success of a new injectable, fast setting bioceramic root repair material (BC RRM) putty with mineral trioxide aggregate (MTA) in pulpotomy procedures of primary teeth. The null hypothesis (H0) is that there is no difference in the clinical and radiographic success between the TotalFill® BC RRM™ Fast Set Putty and Produits Dentaires™ (PD™) MTA WHITE when used as a pulp dressing in pulpotomies of primary molars.
详细描述
Dental Caries is the most common chronic disease worldwide and the most common disease of childhood, with increasing prevalence in many countries, including Egypt. About 70% of Egyptian children have some untreated caries experience. This percentage was also reported by an unpublished nationwide survey funded by the World Health Organization (WHO).
Dental decay is the primary cause for oral pain and tooth loss. Toothache as a result of untreated caries is persistent and often severe. In children, the prevalence of dental pain ranges from 5% to 33% and increases with caries severity, child age and decreasing economic status. Untreated caries in children can lead to pain, sepsis and affect the quality of life of children and their families, such as lost school days, family disruption, and the need for costly dental treatment.
Tooth decay has a multifactorial nature of occurrence. The carious process is a result of an imbalance between pathogenic factors, namely the high frequency of fermentable sugar intake and the increase in acid-producing bacteria, which outweigh host protective factors in the oral cavity favoring demineralization of the tooth structure. This on-going process progresses more rapidly in primary compared to permanent teeth which may be attributed to the different anatomical characteristics between them. Thinner enamel and dentin as well as larger pulp and higher pulp horns make deciduous teeth more vulnerable to degradation of hard tissues and pulpal affection. Approximately 75% of deep carious lesions were found clinically with pulp exposure.
The deciduous teeth are important for mastication, speech, esthetics as well as for the preservation of arch integrity and space for the permanent successors. Hence, pulp therapy is the appropriate alternative to extraction for pulpally affected primary teeth in most clinical situations. Depending on the extension of the carious process, different pulp treatment modalities are available, pulpotomy being the most common among them with a high success rate of 82.6%. Complete pulpotomy involves the complete removal of the inflamed and/or infected coronal pulp tissue and the application of a medicament to the pulp chamber or radicular pulp remnants allowing healing of the radicular pulp tissue.
For decades, formocresol had been the gold standard material for pulpotomy procedures in primary teeth until mineral trioxide aggregate (MTA) was introduced. According to several systematic reviews and meta-analysis, MTA presents superior performance and higher success rates compared to other materials in pulpotomy of primary teeth. MTA pulpotomy has become a safe and biocompatible treatment alternative with success rates comparable to formocresol pulpotomy.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to which group they are assigned to. Both materials used have the same white color and any labels on syringes will be hidden with appropriate wrap. Teeth treated will be assigned codes so that outcome evaluators at follow up appointments are blinded. Furthermore, baseline clinical and radiographic findings of sound teeth as well as after pulp therapy and stainless steel crown placement will not reveal the material being used at the intervention, since the stainless steel crown obscures the view clinically and radiographically. On the other hand, the operator/primary investigator cannot be blinded as she is already familiar with the nature of the materials used and their different modes of application. For statistical analysis, codes will also assure blinding and confidentiality.
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy
- •Absence of clinical signs and symptoms; namely pain on percussion, tooth mobility, presence of sinus or fistula or history of swelling
排除标准
- •Badly broken down, unrestorable teeth
- •Teeth with previous pulp therapy treatment
- •Presence of uncontrolled bleeding
- •Clinical evidence of non-vitality; namely presence of an abscess or a sinus tract or premature mobility
- •Radiographic evidence of bone resorption, internal or external root resorption, or periapical or interradicular radiolucency.
- •Uncooperative patients
结局指标
主要结局
Clinical Success of Pulpotomy Treatment after 3 months follow up
时间窗: 3 months
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 3-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Clinical Success of Pulpotomy Treatment after 1 month follow up
时间窗: 1 month
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 1-month evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Clinical Success of Pulpotomy Treatment after 6 months follow up
时间窗: 6 months
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 6-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Clinical Success of Pulpotomy Treatment after 12 months follow up
时间窗: 12 months
During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 12-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility
Radiographic Success of Pulpotomy Treatment after 12 months follow up
时间窗: 12 months
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 12-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Radiographic Success of Pulpotomy Treatment after 3 months follow up
时间窗: 3 months
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 3-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Radiographic Success of Pulpotomy Treatment after 1 month follow up
时间窗: 1 month
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 1-month evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
Radiographic Success of Pulpotomy Treatment after 6 months follow up
时间窗: 6 months
During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 6-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency
次要结局
- Ease of handling of material(during procedure)
- Convenience of application(during procedure)
- Time to perform procedure(during procedure)
研究者
Dina Hisham Abdelwahab
Assistant Lecturer of Pediatric Dentistry and Dental Public Health
Ain Shams University