Clinical and Radiographic Efficacy of Chloramphenicol, Tetracycline, Zinc Oxide and Eugenol Paste (CTZ Paste) in the Context of Emergency Dental Treatments in Brazilian Public Health: Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Pain Resolution and Clinical Infection Control
研究概览
简要总结
The treatment of pulpal diseases in primary teeth represents a significant challenge in public health, particularly in emergency dental care settings, where factors such as limited clinical time, low child cooperation, and structural constraints directly impact treatment effectiveness. In these contexts, conventional pulpectomy using zinc oxide-eugenol (ZOE), although effective, may present operational limitations that restrict its large-scale applicability in public health systems.
In this scenario, non-instrumental endodontic treatment (NIET), based on the concept of Lesion Sterilization and Tissue Repair (LSTR), has emerged as a simplified alternative. Among the available options, CTZ paste shows potential for single-visit application, reducing clinical time and technical complexity.
This study aims to evaluate the clinical and radiographic non-inferiority of CTZ paste compared to conventional pulpectomy with ZOE in primary molars with pulp necrosis, with or without abscess or fistula, treated in emergency dental care settings.
This is a randomized, pragmatic, controlled, non-inferiority clinical trial conducted at a single center, with clinical and radiographic follow-up at 3, 6, and 12 months. Participants will be allocated into two groups: (1) NIET with CTZ paste and (2) conventional pulpectomy with ZOE.
Primary outcomes include pain resolution and absence of clinical signs of infection. Secondary outcomes include radiographic success, clinical time, child behavior (Frankl Scale), need for retreatment, and oral health-related quality of life.
The findings are expected to provide robust evidence regarding the effectiveness of CTZ paste under real-world clinical conditions, contributing to the development of more accessible and effective protocols within public health systems, with the potential to expand access to conservative treatment and reduce early tooth extractions in pediatric dentistry.
详细描述
Pulpal diseases in primary teeth remain a significant challenge in public health, particularly in emergency dental care settings. These environments are often characterized by limited clinical time, reduced child cooperation, and structural constraints, all of which may compromise the effectiveness and feasibility of conventional treatments. Pulpectomy using zinc oxide-eugenol (ZOE) is widely recognized as an effective treatment for necrotic primary teeth; however, its technical complexity and time requirements may limit its applicability in high-demand public healthcare systems.
In this context, non-instrumental endodontic treatment (NIET), based on the concept of Lesion Sterilization and Tissue Repair (LSTR), has been proposed as a simplified and less time-consuming alternative. This approach aims to disinfect the root canal system using antimicrobial pastes without mechanical instrumentation. Among these, CTZ paste has shown promising results due to its antimicrobial properties, ease of use, and potential for single-visit treatment, making it particularly suitable for emergency care scenarios.
The present study is designed to evaluate whether CTZ paste is non-inferior to conventional pulpectomy with ZOE in the treatment of primary molars diagnosed with pulp necrosis, with or without the presence of abscess or fistula, in emergency dental care settings.
This is a randomized, controlled, pragmatic, non-inferiority clinical trial conducted at a single center. Eligible participants will be children presenting with necrotic primary molars requiring urgent dental treatment. After enrollment, participants will be randomly allocated into two groups: (1) non-instrumental endodontic treatment using CTZ paste and (2) conventional pulpectomy using ZOE.
All procedures will be performed according to standardized clinical protocols. Clinical and radiographic evaluations will be conducted at baseline and at follow-up intervals of 3, 6, and 12 months. Blinded outcome assessment will be performed whenever feasible to minimize bias.
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)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients presenting with:
- •Irreversible pulpitis in primary molars;
- •Pulp necrosis, with or without abscess, in primary molars.
- •Primary molars with sufficient remaining tooth structure to allow endodontic treatment.
- •Primary teeth in which the permanent successor tooth germ presents developmental stages compatible with Nolla stages 1 to 7, defined as:
- •Stage 1: Presence of bony crypt with no evidence of calcification; Stage 2: Initial calcification, with appearance of radiopaque points in the crown region; Stage 3: Approximately one-third of crown formation; Stage 4: Approximately two-thirds of crown formation; Stage 5: Crown almost complete, without full calcification; Stage 6: Crown completely formed, without initiation of root formation; Stage 7: Initial root formation.
- •Clinical and radiographic conditions indicating feasibility of tooth maintenance through endodontic treatment, including:
- •Permanent successor in developmental stages prior to Nolla Stage 8;
- •Preservation of the bony crypt.
排除标准
- •Pediatric patients presenting with:
- •Reversible pulpitis;
- •Indication for endodontic treatment in permanent teeth.
- •History of allergy or hypersensitivity to any components of the obturation materials (e.g., CTZ paste or zinc oxide-eugenol).
- •Clinical conditions that prevent adequate management in an outpatient setting.
- •Primary teeth in which the permanent successor:
- •Is in advanced developmental stages (Nolla Stage 8 or higher), and/or
- •Presents disruption of the bony crypt, contraindicating endodontic treatment.
- •Teeth presenting internal root resorption that compromises the feasibility of endodontic treatment.
研究组 & 干预措施
ZOE Pulpectomy
Conventional pulpectomy involving mechanical instrumentation of root canals, irrigation, and obturation with zinc oxide-eugenol paste.
干预措施: ZOE Pulpectomy (Procedure)
CTZ Paste (NIET)
Participants will receive non-instrumental endodontic treatment (NIET) using CTZ paste in a single visit for the management of necrotic primary molars in an emergency dental care setting.
干预措施: CTZ Paste (Drug)
结局指标
主要结局
Pain Resolution and Clinical Infection Control
时间窗: Up to 7 days post-treatment (primary endpoint), with follow-up assessments at 3, 6, and 12 months.
Resolution of dental pain and absence of clinical signs of infection following emergency endodontic treatment in primary molars. Pain will be assessed using the Wong-Baker Faces Pain Rating Scale, a validated scale for measuring pain intensity in children. Scores range from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." Higher scores indicate greater pain intensity (worse outcome). Infection control will be determined by the absence of clinical signs such as swelling, fistula, abscess, or pathological mobility. The outcome will also consider the need for unplanned additional interventions as an indicator of treatment failure.
次要结局
- Child Behaviour and Oral Health-Realated Quality of Life(Baseline and 3, 6, and 12 months after treatment)
研究者
Isabelle Elise Squillace Mendes
Principal investigator
University of Sao Paulo