Clinical Evaluation of 3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations
研究概览
简要总结
The aim of the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are:
- How does 3D-printed ceromer crowns compare clincally to stainless steel crowns when restoring posterior molars?
- What is the level of satisfaction of the patient with both materials?
- What is the level of parental satisfaction with both materials?
Study methodology:
This study is a split-mouth clinical trial where participants will receive at least one of each materials in different quadrants of the mouth.
详细描述
This randomized clinical trial is designed following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will adopt a prospective, split-mouth approach. The objective is to compare the clinical performance of crowns fabricated with three-dimensional (3D) printed ceromer material against conventional preformed stainless steel crowns in extensively decayed primary posterior teeth. The unit of observation will be gingival inflammation in the area surrounding the restorations, evaluated at specific time points over a 12-month follow-up period (3, 6 and 12 months).
Each eligible participant will receive both types of crowns, with assignments made to contralateral quadrants of the mouth to allow for within-subject comparison. This methodology minimizes inter-individual variability and strengthens internal validity. The ceromer crowns will be fabricated via additive manufacturing (3D printing), while the stainless steel crowns will follow the conventional selection and crimping technique.
Written informed consent will be obtained from their guardians or parents. An expected total of 50 primary molars of healthy participants will be restored.
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 (Outcomes Assessor)
盲法说明
Due to the esthetic nature of the different materials, masking of the participants and investigators is not possible, however outcomes assessor with be masked.
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 9 years with at least 2 primary molars affected by deep occlusoproximal caries.
- •Teeth may require pulp therapy (pulpotomy or pulpectomy) and be suitable for full-coverage restoration.
- •Teeth must have an antagonist and be located in opposing hemiarches.
- •The affected primary molars must be expected to remain in the mouth for at least 12 months.
- •The child must be in general good health.
- •Parents or legal guardians must sign informed consent, and the child must provide assent.
- •Patient does not come to control appointment or does not want to continue research.
排除标准
- •Children with systemic diseases or medical conditions affecting oral health.
- •Uncooperative behavior (Frankl scale 3 or 4).
- •Temporomandibular joint disorders or parafunctional habits (e.g., bruxism).
- •Absence of antagonist or adjacent teeth in the selected quadrants.
- •Children on long-term medication.
- •Patient with allergy to local anesthetic, nickel or chromium.
结局指标
主要结局
International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations
时间窗: 12 months
Functional, Biological and Esthetic properties, scored from 1-5 (higher score meaning worse result.
Plaque index (PI) (Silness and Loe, 1964)
时间窗: 12 months
0- No plaque in the area adjacent to the gingiva 1. There is a thin film on the edge of the gingival margin. (detected with the help of a probe) 2. There is presence of plaque in the gingival pocket and gingival margin at a level that can be determined by eye. There is no plaque in the proximal area. 3. A large amount of plaque layer is observed in the gingival pocket and gingival margin. Interdental area is filled with plaque.
Gingival Index (GI) (Loe & Silness, 1963)
时间窗: 12 months
0- Healthy gingiva, no inflammation 1. Mild inflammation, discoloration and mild edema of the gums, no bleeding on probing. 2. Moderate inflammation, redness and edema in gums, bleeding on probing. 3. Advanced inflammation, redness, edema in gums, spontaneous bleeding is observed.
次要结局
- Patient satisfaction(6 months)
- Parental satisfaction(6 months)
研究者
Alan Velazquez
D.D.S., M.P.H.
Universidad Autonoma de Baja California