Comparison of Gingival Inflammatory Markers and Clinical Outcomes of Conventional and Prefabricated Band and Loop Space Maintainers: A Split-Mouth Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.Chemokine Levels in GCF:
研究概览
简要总结
Introduction
Early loss of primary teeth due to trauma or caries can leadto dental complications such as crowding, rotation, and midline shifts,potentially resulting in malocclusion. Maintaining the space left byprematurely lost deciduous teeth is essential to prevent orthodontic issues.Conventional band and loop (B&L) space maintainers are widely used, butprefabricated B&L space maintainers offer advantages such as reducedtreatment time and lower technical demands. However, both types have beenassociated with gingival inflammation and plaque accumulation.MacrophageInflammatory Proteins (MIP-1alpha and MIP-1beta) are chemokines involved inperiodontal inflammation. Their role in children with space maintainers is notwell understood. This study aims to evaluate and compare MIP-1alpha and MIP-1beta levels in the gingival crevicular fluid (GCF) of children using conventionaland prefabricated B&L space maintainers, assessing their impact on gingivaland periodontal health.
Objective
The primary objective is to compare MIP-1alpha and MIP-1beta levelsin GCF and their association with gingival inflammation in children usingconventional and prefabricated B&L space maintainers. Secondary objectivesinclude assessing the survival rates, structural integrity, and patientacceptance of both space maintainer
Methodology
This split-mouth randomized controlled study will beconducted at King George’s Medical University. Ethical clearance will beobtained before initiation
Children aged 3-7 years with bilateral loss of mandibularfirst deciduous molars will be enrolled and randomly assigned to receive eithera conventional or prefabricated B&L space maintainer. GCF samples will becollected at baseline and six months, and MIP-1alpha and MIP-1beta levels will beanalyzed using ELISA. Periodontal parameters such as the Gingival Index (GI)and Plaque Index (PI) will be recorded at 1, 3, and 6 months. Survival rates,patient acceptance, and satisfaction will be evaluated through questionnaires.
Statistical analysis will be performed using SPSS software,with a significance level set at p less than 0.05.
Expected Outcomes
This study is expected to reveal differences in inflammatoryresponses between conventional and prefabricated space maintainers.Prefabricated maintainers may result in lower gingival inflammation and higherpatient satisfaction due to better adaptation and reduced plaque accumulation.
Conclusion
Understanding the immunological response to spacemaintainers is crucial for optimizing their design and clinical application. Thisstudy will contribute to improved periodontal health management strategies,enhancing the long-term success of space maintainers in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical Criteria 1 Age group: 4–9years.
- •2 Bilateral loss of mandibular first deciduous molars due to caries.
- •3 No evidence of space loss at the extraction site, with extractions performed within the past 6 months.
- •Radiographic Criteria: 1 Presence of permanent tooth buds beneath the extraction site.
- •2 Adequate bone coverage over the extraction site.
- •3 Absence of root furcation involvement, tooth mobility, or abscess formation in abutment teeth.
排除标准
- •1.Presence of multi-surface dental decay or pulp involvement in abutment teeth.
- •2.Loss of teeth anteriorly or posteriorly adjacent to the edentulous space.
- •3.Abnormal dental conditions or habits such as thumb sucking, tongue thrusting, open bite, or crossbite.
- •4.Presence of tooth mobility, abscess, or any systemic diseases impacting oral health.
结局指标
主要结局
1.Chemokine Levels in GCF:
时间窗: baselines and 6 months
Levels of MIP-1alpha and MIP-1beta in gingival crevicular fluid (GCF) collected from children with conventional and prefabricated band and loop space maintainers, analyzed using ELISA.
时间窗: baselines and 6 months
次要结局
- 1.Clinical Periodontal Parameters:(Gingival Index (GI))