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临床试验/NCT06854744
NCT06854744招募中不适用

Zinc Oxide Ozonated Oil Versus Modified Triple Antibiotic Paste as a Lesion Sterilization and Tissue Repair Technique in Primary Molars

Tanta University4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
4
主要终点
primary out come

研究概览

简要总结

This study will be carried out to evaluate and compare the clinical and radiographic effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars

详细描述

Preservation of primary dentition is crucial for the development of arch form, esthetics, function, mastication, and normal eruption of permanent teeth. Premature loss, especially of the primary second molar, can cause several problems. The first permanent molars typically erupt mesially as a result, leading to some problems including the ectopic eruption of the second premolar, the loss of space for the succeeding permanent teeth and functional impairment 1.

Dental caries is the most prevalent non-communicable disease in children with significant aesthetic, functional, and quality of life deterioration2. Caries lesions can jeopardize the teeth' vitality, as their progression cause infection, pain, and even early tooth loss 2,3. Thus, timely intervention is key to avoid unfavorable repercussions for the child. Depending on the depth of caries (which may have pulp involvement), two approaches may be considered in the primary dentition: vital pulp therapy (VPT) or non-vital therapy (NPT)2,4.

When the pulp can be recovered, VPT may be an option and three options are available: indirect pulp treatment (IPT), direct pulp cap (DPC), and pulpotomy 2-6.

When the caries lesion progresses to the point where the pulp necrotizes, then an NPT is performed, such as a pulpectomy 4. It is a nonvital treatment (NVT), a root canal treatment with irreversibly inflamed or necrotic pulp resulting from caries or trauma 2,4,6,7. Pulpectomy has been the gold-standard treatment for primary teeth with pulp necrosis or irreversible pulp inflammation and is based on the debridement of the root canals with manual or rotary instruments together with the use of antimicrobial irrigation solutions to decontaminate the root canal system for posterior filling with resorbable materials 8 However, the inherent characteristics of the root canal system in primary teeth make this procedure an endodontic challenge, especially in molars 9,10.

In the 1990s, an innovative procedure called lesion sterilization and tissue repair (LSTR) was proposed as an alternative biologic approach that was thought to facilitate the disinfection of dentinal carious lesions, pulp, and periapical lesions in primary teeth 11-13 with the advantages of being simpler and faster 14,15.

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 (Participant)

盲法说明

Group I: Zinc Oxide Ozonated Olive- oil will be applied to the pulp stamps of the molars on one side.

Group II: MTAP will be applied to the pulp stamps of the molars on the other side.

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1- Cooperative patients in the age group of (4-7) years with no associated systemic illness.
  • 2- Bilateral mandibular primary molars showing signs and symptoms of pulp necrosis or chronic pulp infection with/without hemorrhage, suppuration, or purulence.
  • 3- Spontaneous pain or tenderness to percussion. 4- Presence of chronic apical abscess, sinus tract, or grade I mobility. 5-The tooth should be restorable. 6- Radiographic characteristics are:
  • Widening of Periodontal ligament space.
  • Radicular involvement.
  • Furcation involvement less than or equal to half of the shortest root in the vertical dimension

排除标准

  • Exclusion criteria :
  • Physiologic root resorption is more than one-third of its length.
  • Excessive internal resorption.
  • Non-restorable teeth exhibiting greater than grade I mobility.
  • Perforation into the bifurcation.
  • Any underlying pathological lesion.
  • Any previous history of allergy to the antibiotics used in the study. -

结局指标

主要结局

primary out come

时间窗: 3,6,9,12 months

.evaluate clinical outcomes including Absence of pain or tenderness, No tooth mobility, and Presence of healthy soft tissue; no swelling, redness, or sinus tract for both groups including zinc oxide ozonated oil group and MTAP group during the follow-up periods 3,6,9,12 months follow up evaluate radiographic effect of both materials on: Continuity of lamina Dura, Static or reduction in the size of existing pathologic intra-radicular or periapical radiolucency., No newly formed radiographic lesion, Absence of pathological root resorption, and Evidence of bone regeneration utilizing gray value

primary outcome

时间窗: 3,6,9,12 months follow up

evaluate radiograhic effect of both materials on : * Continuity of lamina Dura. * Static or reduction in the size of existing pathologic intra-radicular or periapical radiolucency. * No newly formed radiographic lesion. * Absence of pathological root resorption * Evidence of bone regeneration utilizatig gray value

次要结局

  • secondary out come(12 months follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nouran Esmail Mohamed Shalaby

Zinc Oxide Ozonated Oil Versus Modified Triple Antibiotic Paste as a Lesion Sterilization and Tissue Repair Technique in Primary Molars

Tanta University

研究点 (4)

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