A Comparative Clinical and Radiographic Study of 3Mixstatin vs Tri-Antibiotic Mix and Simvastatin in the Treatment of Primary Molars With Inflammatory Root Resorption A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- Over All Success Rate ( as a percentage)
研究概览
简要总结
The aim of this study is to determine whether the success rate of pulp therapy undergone on primary molars with signs and symptoms of odontogenic infection that may render them indicated for extraction will improve with the use of the Simvastatin alone, the Tri-Antibiotic Mix alone or when in combination together 3Mixstatin as a component in the root filling material.
详细描述
A clinical situation will often present itself where primary teeth under radiographic examination show inter-radicular or periapical root resorption, perforation of coronal third of roots and/or loss of bone support as a result of infective or inflammatory conditions. Pathologic root resorption is the most common cause of premature tooth loss in primary dentition. The reason for that may be the high content of undifferentiated mesenchymal cells, which may give rise to odontoclastic cells in response to either the caries process or the pulp-capping materials, resulting in the exaggerated inflammatory response and consequently internal resorption in primary teeth. It would make sense to utilize the rich supply of undifferentiated mesenchymal cells towards regeneration of remaining dental tissues.
Antibiotic Mix as an intracanal medicament
In recent years, the Cariology Research Unit of Niigata University School of Dentistry has developed the concept of lesion sterilization and tissue repair (LSTR) therapy that employed a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected if lesions are disinfected. This procedure uses a mixture of three antibacterial drugs (3Mix MP) as a root canal medicament to eliminate the remaining bacteria in endodontic lesions. The medicament consists of metronidazole, ciprofloxacin and minocycline - with macrogol (M) as the ointment base and propylene glycol (P) as the carrier Alone, none of these drugs resulted in complete elimination of the bacteria. However, in combination, these drugs were able to consistently sterilize all samples.
Although a local antibiotic medication in endodontics offers many advantages, this mode has some drawbacks, including development of bacterial resistant strains. That is a major concern and may lead to the transfer of resistance genes from antibiotic-resistant to antibiotic-susceptible microorganisms. Other drawbacks include allergic reactions inhibition of angiogenesis , and tooth staining or discoloration particularly with Minocycline. More importantly is that although the concept of Lesion sterilization and tissue repair (LSTR) therapy is that it provides an efficient and predictable disinfection, through 3 Mix on a local level and providing the suitable environment for tissues to heal, it does not in itself have any anti-inflammatory nor regenerative potential. Statins may provide these two benefit.
Choice of comparator Statins are structural analogs of HMG-CoA (3hydroxy-3-methylglutaryl-coenzyme A). These drugs are the first-line for hyperlipidemia and it has been recognized to be a safe and low-priced drug as a result of its worldwide longtime usage. Moreover, statins have multiple functions including anti-inflammation, induction of angiogenesis and improvement of the vascular endothelial cell function. Another interesting and important function of statin is its effect on bone formation. It has been reported that several statins such as simvastatin and lovastatin have anabolic effects on bone metabolism at in vitro and in vivo studies. They promote mineralization in non-mineralizing osteoblasts through induction of BMP-2 and osteocalcin. Local application of simvastatin gel has shown to stimulate the regeneration of alveolar bone defects Statins have an anti-inflammatory effect. They act by decreasing the production of interleukin-6 and interleukin-8 and may also improve the function of odontoblasts, thus dentin formation.
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
Every participant will grasp an opaque sealed envelop from a box after diagnosis of the case. Being opaque and sealed ensures allocation concealment. Envelopes have been assigned to RN who is not involved in neither the diagnosis nor the treatment phases of the cases.
入排标准
- 年龄范围
- 5 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young cooperative patients with no history of systemic disease that may contraindicate pulp therapy
- •Age range 4-6 years.
- •Patient has at least one restorable primary molar that exhibits signs and symptoms of odontogenic infection with inflammatory root resorption and require pulpectomy,
- •Patient's parents are willing to participate in this study and will be able to follow up Clinical & Radiographic Criteria for Case Selection Signs and symptoms of irreversible pulpitis as well as inter-radicular, or periapical root resorption as a result of infective or inflammatory conditions that may render the tooth hopeless and indicated for extraction
- •Clinical Criteria (include):
- •Spontaneous pain
- •Intraoral Abscess
- •Extra oral Abscess
- •Tender to percussion
- •Presence of abnormal mobility other than that associated with exfoliation
- •Radiographic Criteria include:
- •Radiolucency in furcation area
- •Periapical root resorption or excessive bone destruction and/or perforation in coronal third of roots as a result of infective or inflammatory conditions.
排除标准
- •Patients with systemic disease
- •Patients who cannot attend follow up.
- •Primary molars that are unrestorable
- •Primary molars exhibiting pathology of permanent tooth follicle
研究组 & 干预措施
Triple antibiotic paste
Pulpectomy for primary molars, triple antibiotic mix is used as obturating material mixed with Macrogol and Polyethylene glycol & small amount of Zinc oxide powder to obtain workable , radio opaque mix
干预措施: Pulpectomy for primary molars + triple antibiotic mix (Procedure)
3mixstatin
Pulpectomy for primary molars, 3 Mixstatin ( mix of simvastatin and triple antibiotic mix ) is used as obturating material mixed with Macrogol and Polyethylene glycol & small amount of Zinc oxide powder to obtain workable , radio opaque mix
干预措施: Pulpectomy for primary molars + 3mixstatin (Procedure)
simvastatin
Pulpectomy for primary molars, simvastatin is used as obturating material mixed with Macrogol and Polyethylene glycol & small amount of Zinc oxide powder to obtain workable , radio opaque mix
干预措施: Pulpectomy for primary molars + simvastatin (Procedure)
结局指标
主要结局
Over All Success Rate ( as a percentage)
时间窗: 12 months
For each group Number of cases exhibiting success criterion at 12 months / Total number of cases x 100 At the end of the follow up period, the cases are considered successful if they exhibited ALL the following criteria: * Absence of tenderness to percussion * No abnormal mobility * Absence of swelling and fistula * Absence or decrease of furcation radiolucency * Absence or decrease of radicular radiolucency * Absence of Internal/external root resorption or other pathological changes The cases were considered as total (overall) failures if they failed clinically at the 3, 6 or 12 months; or when they failed radiographically at the 12 months follow-up. Otherwise they will be considered as a success.
次要结局
- Bone density changes in Region of Interest ROI(12 months)
研究者
Dina El Kharadly
Assistant lecturer
October 6 University
