Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Crown retention
研究概览
简要总结
This study will be conducted to:
Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.
详细描述
A randomized controlled clinical trial with three parallel groups, will be set up and reported according to the revised Consolidated Standards of Reporting Trials statement. The study will be conducted on 51 children with 51 molars aged between 4 and 7 years with a lower primary molar indicated for crown restoration. The children will be selected from the Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. They will be randomly divided into three equal groups (17 molars/each). Sequence generation and concealment will be done by a biostatistician who is not involved in the study. Group I (control group) will include stainless steel crowns, group II (study group) will include Zirconia crowns, group III (study group) will include BioFlx crowns. After obtaining the written consent form from the parents or guardians, the children will be randomly enrolled, and teeth will be assigned to the groups to receive the selected crowns. Clinical evaluation will be done concerning crown retention, color stability, secondary caries, periodontal changes, and wear of the opposing natural enamel. All crowns will be evaluated at the 3rd, 6th, 12th, and 18th months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Children who are free from any systemic disease.
- •Children with a carious lower primary molar indicated for crown restoration.
- •Teeth with an intact antagonist and neighboring primary molar.
- •Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.
排除标准
- •Children with extremely poor oral hygiene.
- •Teeth showing radiographical furcation involvement or root resorption.
- •Children with para-functional habits, bruxism, or deep bite.
- •Teeth with inadequate non-restorable crown structure.
结局指标
主要结局
Crown retention
时间窗: After 3, 6,12,18 months
The crown retention will be measured concerning the proper adaptation of the crown or the complete crown loss according to the following: 0 = present. 1 = absent.
Periodontal pocket depth (Periodontal changes)
时间窗: After 3, 6, 12 ,18 months
The PPD will be measured using a manual periodontal probe (UNC. 15 mm) according to the following: The pocket depth will be measured in mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The periodontal probe will be inserted into the gingival sulcus parallel to the longitudinal axis of the tooth and then move in a walking fashion.
Secondary caries
时间窗: After 3, 6, 12,18 months
Secondary caries will be measured according to USPHS by visual inspection with an explorer to inspect if there is evidence of caries with the margin of the crown restoration according to the following: 0 = no caries 1 = caries present
Gingival Index (Periodontal Changes)
时间窗: After 3, 6, 12 ,18 months
The GI (Gingival index) will be measured by the William Gingival Probe; the values will be recorded according to the following: 0 = normal gingiva 1. = mild inflammation: a slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation: redness, edema, glazing, or bleeding on probing 3. = severe inflammation: marked redness or edema, a tendency toward spontaneous bleeding, and ulceration.
Color stability
时间窗: After 3, 6,12,18 months
The color stability will be evaluated using one crown from the original kit as a standard that will be held up to each crown restoration for color comparison according to the following: 0= Unchanged. 1= Minor deviation from original. 2 = Unacceptable discoloration.
Periodontal Index (Periodontal changes)
时间窗: After 3, 6, 12 ,18 months
The PI (Periodontal Index) will be measured by the William Gingival probe; the values will be recorded according to the following: 0 = no plaque 1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.
Wear of the opposing natural enamel.
时间窗: After 12 months
To evaluate the wear of the antagonistic natural enamel of the primary molar, alginate impressions will be taken immediately (baseline) and 1 year after cementation of the crowns. The resulting casts will be scanned using a 3D scanner and 3D software that will be used to calculate the maximum amount of linear wear using image superimposition techniques. The occlusal points of the crowns will be recorded in the software for measurements and comparisons, then it will be transformed into Standard Tessellation Language (STL) file format by the software
次要结局
未报告次要终点
研究者
Heba Elbadry
Assistant lecturer, peadiatric dentistry department
Mansoura University